Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001) (NCT NCT01295827)

Last Updated: 2019-12-13

Results Overview

DLTs were assessed according to NCI-CTCAE v.4.0 during the first cycle (28 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥14 days; Gr 3 nonhematologic toxicity lasting \>3 days despite optimal supportive care; any Grade 3 non-hematologic laboratory value if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for \>1 week; Gr 3 or 4 febrile neutropenia; thrombocytopenia \<25,000 cells/mm\^3 (if associated with a bleeding event requiring an elective platelet transfusion, or a life-threatening bleeding event which resulted in urgent intervention and admission to an Intensive Care Unit); or Gr 5 toxicity. The number of participants in Part A and Part A1 with a DLT were reported by pembrolizumab dose received.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

1260 participants

Primary outcome timeframe

Up to 28 days in Cycle 1

Results posted on

2019-12-13

Participant Flow

Participants with a histologically- or cytologically-confirmed diagnosis of any type of carcinoma (solid tumors), melanoma (MEL), or non-small cell lung cancer (NSCLC), with progressive locally advanced or metastatic disease, were recruited.

Of 1260 participants enrolled or randomized to the study, 1235 received at least one dose of treatment (All Treated Population) and were evaluable for all safety and efficacy analyses. Part E did not enroll any participants.

Participant milestones

Participant milestones
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab intravenous (IV) infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg every 2 weeks (Q2W) starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Overall Study STARTED	4	3	12	4	3	6	164	321	183	61	296	203
Overall Study Treated (All Treated Population)	4	3	10	4	3	6	162	313	180	61	287	202
Overall Study COMPLETED	0	0	0	0	1	0	18	24	14	6	20	17
Overall Study NOT COMPLETED	4	3	12	4	2	6	146	297	169	55	276	186

Reasons for withdrawal

Reasons for withdrawal
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab intravenous (IV) infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg every 2 weeks (Q2W) starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Overall Study Adverse Event	1	2	2	1	1	4	15	49	22	7	50	21
Overall Study Lost to Follow-up	0	0	3	0	1	0	4	8	7	4	7	3
Overall Study Not Reported	0	0	0	1	0	0	24	58	41	2	23	13
Overall Study Progressive Disease	2	1	5	2	0	1	87	144	85	40	175	136
Overall Study Screen Failure	0	0	0	0	0	0	2	2	2	0	1	0
Overall Study Withdrawal by Subject	1	0	2	0	0	1	13	35	11	2	18	13
Overall Study Other	0	0	0	0	0	0	1	1	1	0	2	0

Baseline Characteristics

Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=12 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=6 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=164 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=321 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=183 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=296 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=203 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	Total n=1260 Participants Total of all reporting groups
Age, Continuous	71.0 Years STANDARD_DEVIATION 6.4 • n=5 Participants	76.0 Years STANDARD_DEVIATION 8.7 • n=7 Participants	62.7 Years STANDARD_DEVIATION 16.1 • n=5 Participants	53.8 Years STANDARD_DEVIATION 11.7 • n=4 Participants	53.3 Years STANDARD_DEVIATION 23.5 • n=21 Participants	69.0 Years STANDARD_DEVIATION 7.6 • n=10 Participants	57.9 Years STANDARD_DEVIATION 13.5 • n=115 Participants	60.5 Years STANDARD_DEVIATION 13.5 • n=24 Participants	60.1 Years STANDARD_DEVIATION 14.4 • n=42 Participants	61.9 Years STANDARD_DEVIATION 11.0 • n=42 Participants	61.8 Years STANDARD_DEVIATION 11.2 • n=42 Participants	63.0 Years STANDARD_DEVIATION 10.2 • n=42 Participants	61.0 Years STANDARD_DEVIATION 12.6 • n=36 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	69 Participants n=115 Participants	125 Participants n=24 Participants	122 Participants n=42 Participants	29 Participants n=42 Participants	145 Participants n=42 Participants	91 Participants n=42 Participants	589 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	95 Participants n=115 Participants	196 Participants n=24 Participants	61 Participants n=42 Participants	32 Participants n=42 Participants	151 Participants n=42 Participants	112 Participants n=42 Participants	671 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	12 Participants n=115 Participants	13 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	20 Participants n=42 Participants	8 Participants n=42 Participants	63 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	152 Participants n=115 Participants	308 Participants n=24 Participants	180 Participants n=42 Participants	60 Participants n=42 Participants	274 Participants n=42 Participants	195 Participants n=42 Participants	1195 Participants n=36 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=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 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	2 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	6 Participants n=24 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	46 Participants n=42 Participants	19 Participants n=42 Participants	81 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	12 Participants n=42 Participants	8 Participants n=42 Participants	26 Participants n=36 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants	161 Participants n=115 Participants	310 Participants n=24 Participants	178 Participants n=42 Participants	53 Participants n=42 Participants	237 Participants n=42 Participants	174 Participants n=42 Participants	1144 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 28 days in Cycle 1

Population: All participants in Parts A and A1 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of pembrolizumab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of pembrolizumab without experiencing DLT. Per protocol, Parts A2 and B-F were not analyzed.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1)	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)

Population: All participants who received at least 1 dose of study treatment.

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for each arm.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=6 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Number of Participants Who Experienced an Adverse Event (AE)	4 Participants	3 Participants	9 Participants	4 Participants	3 Participants	6 Participants	161 Participants	308 Participants	178 Participants	60 Participants	277 Participants	198 Participants

PRIMARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

Population: All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.

ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRO was reported as the ORR for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	30.2 Percentage of Participants Interval 23.3 to 37.9	29.4 Percentage of Participants Interval 24.4 to 34.8	36.7 Percentage of Participants Interval 29.6 to 44.2	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

Population: All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.

ORR was defined as the percentage of participants in the analysis population who had a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRC was reported as the ORR for each NSCLC dose arm (Parts C plus F).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	19.7 Percentage of Participants Interval 10.6 to 31.8	21.6 Percentage of Participants Interval 17.0 to 26.8	19.3 Percentage of Participants Interval 14.1 to 25.4

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

ORR was defined as the percentage of participants in the analysis population who had a confirmed immune-related Complete Response (irCR: complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or immune-related Partial Response (irPR: decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
ORR According to Immune-related Response Criteria (irRC) as Assessed by Investigator in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	35.2 Percentage of Participants Interval 27.9 to 43.1	39.9 Percentage of Participants Interval 34.5 to 45.6	45.6 Percentage of Participants Interval 38.1 to 53.1	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

ORR was defined as the percentage of participants in the analysis population who had a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each NSCLC dose arm (Parts C plus F).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
ORR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	23.0 Percentage of Participants Interval 13.2 to 35.5	28.9 Percentage of Participants Interval 23.7 to 34.5	22.3 Percentage of Participants Interval 16.7 to 28.6

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)

Population: All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-28 data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose pharmacokinetic (PK) analysis.

Blood samples were collected at specified intervals for the determination of AUC0-28. AUC0-28 was defined as the area under the concentration-time curve of pembrolizumab from time zero to Day 28. AUC0-28 was based on noncompartmental analysis and reported for participants in Parts A and A1.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=9 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 28 (AUC 0-28) in Solid Tumor Participants (Parts A and A1)	157 μg•day/mL Geometric Coefficient of Variation 16	955 μg•day/mL Geometric Coefficient of Variation 23	2160 μg•day/mL Geometric Coefficient of Variation 31	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)

Population: All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-inf data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.

Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. AUC0-inf was based on noncompartmental analysis and reported for participants in Parts A and A1.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=9 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Infinity (AUC 0-inf) in Solid Tumor Participants (Parts A and A1)	212 μg•day/mL Geometric Coefficient of Variation 36	1530 μg•day/mL Geometric Coefficient of Variation 28	3230 μg•day/mL Geometric Coefficient of Variation 44	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)

Population: All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.

Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Cmax was based on noncompartmental analysis and reported for participants in Parts A and A1.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Maximum Concentration (Cmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)	16.4 μg/mL Geometric Coefficient of Variation 22	107 μg/mL Geometric Coefficient of Variation 26	256 μg/mL Geometric Coefficient of Variation 37	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)

Population: All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.

Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Tmax was based on noncompartmental analysis and reported for participants in Parts A and A1.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Time to Maximum Concentration (Tmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)	0.05 days Interval 0.02 to 0.17	0.17 days Interval 0.17 to 0.17	0.17 days Interval 0.03 to 0.99	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)

Population: All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available t½ data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.

Blood samples were collected at specified intervals for the determination of t½. t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. t½ was based on noncompartmental analysis and reported for participants in Parts A and A1.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=9 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Terminal Half-Life (t ½) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)	14.1 days Geometric Coefficient of Variation 51	21.6 days Geometric Coefficient of Variation 10	17.5 days Geometric Coefficient of Variation 54	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours; Day 5, Day 8: pre- and post-dose; Day 15 (Cycle = 21 days)

Population: All participants in Part A2 receiving escalating doses of drug during Cycle 1 (21 days) and having available AUC0-21 data. One participant was excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis.

Blood samples were collected at specified intervals for the determination of AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of pembrolizumab from time zero to Study Day 21. AUC0-21 was based on noncompartmental analysis and reported for participants in Part A2.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=5 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 21 (AUC 0-21) in Solid Tumor Participants (Part A2)	—	—	—	57.1 μg•day/mL Geometric Coefficient of Variation 21	50.4 μg•day/mL Geometric Coefficient of Variation 28	186 μg•day/mL Geometric Coefficient of Variation 28	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day 21; Cycle 2: Day 1: Pre-dose, post-dose at 0.5 and 24 hours, Day 3, Day 8, Day 15 (Cycle = 21 days)

Population: All participants in Part A2 receiving escalating doses of drug during Cycle 1 and having available AUC21-42 data during Cycle 2. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis.

Blood samples were collected at specified intervals for the determination of AUC21-42. AUC21-42 was defined as the area under the concentration-time curve of pembrolizumab from Study Day 21 (end of Cycle 1) through Study Day 42 (end of Cycle 2). AUC21-42 was based on noncompartmental analysis and reported for participants in Part A2.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=2 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=5 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Area Under the Concentration-Time Curve of Pembrolizumab From Day 21 to Day 42 (AUC21-42) in Solid Tumor Participants (Part A2)	—	—	—	486 μg•day/mL Geometric Coefficient of Variation 16	348 μg•day/mL Geometric Coefficient of Variation 18	2280 μg•day/mL Geometric Coefficient of Variation 24	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Parts A and A1: pre-dose at Cycles 2, 4, 6, 8, 10, 12, 14 (cycle=14 days); A2 Cohorts: pre-dose at Cycles 2, 3, 5, 7, 9, 11 (cycle=21 days)

Population: All Part A participants receiving ≥1 dose of drug and having available Ctrough samples collected pre-dose before each cycle. Due to differing dosing schedules or N\<1, some time points were not applicable for certain arms if data were not collected or analyzed (indicated by zero participants analyzed entered in the table).

Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration of pembrolizumab reached before the next dose was administered. Ctrough was reported for each Part A arm according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N\>1 at that timepoint. Ctrough data for melanoma (Parts B and D) and NSCLC (Parts C and F) participants are presented separately and are not included here.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=8 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=5 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 2 (Day 21)	—	—	—	2.3 μg/mL Geometric Coefficient of Variation 46.2	1.9 μg/mL Geometric Coefficient of Variation 19.9	7.77 μg/mL Geometric Coefficient of Variation 46.1	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 2 (Day 28)	2.19 μg/mL Geometric Coefficient of Variation 62.4	18.8 μg/mL Geometric Coefficient of Variation 42.1	41.7 μg/mL Geometric Coefficient of Variation 44.6	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 3 (Day 42)	—	—	—	10.6 μg/mL Geometric Coefficient of Variation 15.9	11.1 μg/mL Geometric Coefficient of Variation 28.9	70.1 μg/mL Geometric Coefficient of Variation 15.6	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 4 (Day 56)	6.45 μg/mL Geometric Coefficient of Variation 13	50.0 μg/mL Geometric Coefficient of Variation 36.9	122 μg/mL Geometric Coefficient of Variation 37.2	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 5 (Day 84)	—	—	—	14.8 μg/mL Geometric Coefficient of Variation 33.4	18.3 μg/mL Geometric Coefficient of Variation 34.1	126 μg/mL Geometric Coefficient of Variation 53.9	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 6 (Day 84)	9.93 μg/mL Geometric Coefficient of Variation 5.6	55.2 μg/mL Geometric Coefficient of Variation 33.8	168 μg/mL Geometric Coefficient of Variation 49.5	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 8 (Day 112)	—	66.8 μg/mL Geometric Coefficient of Variation 11.1	260 μg/mL Geometric Coefficient of Variation 1.4	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 7 (Day 126)	—	—	—	29.9 μg/mL Geometric Coefficient of Variation 7.3	22.1 μg/mL Geometric Coefficient of Variation 49.2	151 μg/mL Geometric Coefficient of Variation 48	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 10 (Day 140)	—	63.0 μg/mL Geometric Coefficient of Variation 29.8	200 μg/mL Geometric Coefficient of Variation 4.9	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 9 (Day 168)	—	—	—	29.8 μg/mL Geometric Coefficient of Variation 1	—	150 μg/mL Geometric Coefficient of Variation 29.4	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 12 (Day 168)	—	62.8 μg/mL Geometric Coefficient of Variation 1.7	—	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 14 (Day 196)	—	54.1 μg/mL Geometric Coefficient of Variation 4.3	—	—	—	—	—	—	—	—	—	—
Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) Cycle 11 (Day 210)	—	—	—	40.7 μg/mL Geometric Coefficient of Variation 38.6	—	179 μg/mL Geometric Coefficient of Variation 37.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B arms treated every 3 weeks: pre-dose at Cycles 2,5,9,13,17,25,33 (cycle=21 days); Part B treated every 2 weeks: pre-dose at Cycles 2,3,7,13,19,25,31,37 (cycle=14 days); Part D: pre-dose at Cycles 2,3,6,8,12,16,24,32 (cycle=21 days)

Population: All melanoma participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table).

Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration of pembrolizumab reached before the next dose was administered. For the purposes of the Ctrough analysis, samples were collected and analyzed separately for each Part B and D enrolment cohort, and Ctrough was reported for each cohort according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N\>1 at that timepoint. Ctrough data for solid tumor (Part A) and NSCLC (Parts C and F) participants are presented separately and are not included here.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=91 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=208 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=150 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=52 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=48 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 2 (Day 14)	—	—	63.7 µg/mL Geometric Coefficient of Variation 13.6	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 2 (Day 21)	8.69 µg/mL Geometric Coefficient of Variation 48.9	48.5 µg/mL Geometric Coefficient of Variation 37.9	—	10.1 µg/mL Geometric Coefficient of Variation 56.3	62.6 µg/mL Geometric Coefficient of Variation 37.2	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 3 (Day 28)	—	—	94.0 µg/mL Geometric Coefficient of Variation 47.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 3 (Day 42)	—	80.3 µg/mL Geometric Coefficient of Variation 1.2	—	16.8 µg/mL Geometric Coefficient of Variation 57.2	94.3 µg/mL Geometric Coefficient of Variation 37.1	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 5 (Day 84)	19.5 µg/mL Geometric Coefficient of Variation 58.3	119 µg/mL Geometric Coefficient of Variation 50.7	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 7 (Day 84)	—	—	173 µg/mL Geometric Coefficient of Variation 49.7	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 6 (Day 105)	—	—	—	25.3 µg/mL Geometric Coefficient of Variation 52.4	132 µg/mL Geometric Coefficient of Variation 45.6	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 7 (Day 126)	—	89.2 µg/mL Geometric Coefficient of Variation 34.4	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 12 (Day 231)	—	193 µg/mL Geometric Coefficient of Variation 21.1	—	29.3 µg/mL Geometric Coefficient of Variation 34.7	173 µg/mL Geometric Coefficient of Variation 38.9	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 18 (Day 238)	—	—	171 µg/mL Geometric Coefficient of Variation 27.7	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 13 (Day 252)	27.2 µg/mL Geometric Coefficient of Variation 50.4	153 µg/mL Geometric Coefficient of Variation 39.6	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 25 (Day 336)	—	—	242 µg/mL Geometric Coefficient of Variation 39.9	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 8 (Day 147)	—	166 µg/mL Geometric Coefficient of Variation 5.1	—	23.5 µg/mL Geometric Coefficient of Variation 50.1	152 µg/mL Geometric Coefficient of Variation 40.7	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 9 (Day 168 )	25.5 µg/mL Geometric Coefficient of Variation 59.6	161 µg/mL Geometric Coefficient of Variation 38.4	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 13 (Day 168)	—	—	232 µg/mL Geometric Coefficient of Variation 44.1	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 19 (Day 252)	—	—	253 µg/mL Geometric Coefficient of Variation 37.5	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 16 (Day 315)	—	—	—	30.5 µg/mL Geometric Coefficient of Variation 50.6	183 µg/mL Geometric Coefficient of Variation 37.8	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 24 (Day 322)	—	—	246 µg/mL Geometric Coefficient of Variation 18.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 17 (Day 336)	31.4 µg/mL Geometric Coefficient of Variation 48.9	168 µg/mL Geometric Coefficient of Variation 48.5	—	—	157 µg/mL Geometric Coefficient of Variation 47	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 31 (Day 420)	—	—	184 µg/mL Geometric Coefficient of Variation 29.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 33 (Day 448)	—	—	80.0 µg/mL Geometric Coefficient of Variation 57.9	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 24 (Day 483)	—	152 µg/mL Geometric Coefficient of Variation 7.5	—	30.3 µg/mL Geometric Coefficient of Variation 40.1	147 µg/mL Geometric Coefficient of Variation 47.0	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 25 (Day 504)	29.3 µg/mL Geometric Coefficient of Variation 42.4	165 µg/mL Geometric Coefficient of Variation 41.4	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 37 (Day 504)	—	—	232 µg/mL Geometric Coefficient of Variation 63.8	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 32 (Day 651)	—	—	—	23.0 µg/mL Geometric Coefficient of Variation 44.6	155 µg/mL Geometric Coefficient of Variation 38.5	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 48 (Day 658)	—	—	169 µg/mL Geometric Coefficient of Variation 25.3	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 33 (Day 672)	31.4 µg/mL Geometric Coefficient of Variation 34.0	166 µg/mL Geometric Coefficient of Variation 37.7	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) Cycle 49 (Day 672)	—	—	255 µg/mL Geometric Coefficient of Variation 42.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part C: pre-dose at Cycles 2,5,9,13,17,21 (cycle=21 days); Part F treated every 3 weeks: pre-dose at Cycles 2,3,6,8,12,14,16,24,32 (cycle=21 days); Part F treated every 2 weeks: pre-dose at Cycles 2,3,6,7,8,9,12,16,18,24,32,36,40,48 (cycle=14 days)

Population: All NSCLC participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table).

Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration reached by pembrolizumab before the next dose was administered. For the purposes of the Ctrough analysis, samples were collected and analyzed separately for each Part C and F enrolment cohort, and Ctrough was reported for each cohort according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N\>1 at that timepoint. Ctrough data for solid tumor (Part A) and melanoma (Parts B and D) participants are presented separately and are not included here.

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=33 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=44 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=186 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=230 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 2 (Day 21)	52.0 µg/mL Geometric Coefficient of Variation 31.7	8.23 µg/mL Geometric Coefficient of Variation 41.1	—	43.6 µg/mL Geometric Coefficient of Variation 42.6	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 25 (Day 504)	207 µg/mL Geometric Coefficient of Variation 67.9	—	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 33 (Day 672)	—	40.6 µg/mL Geometric Coefficient of Variation 32.5	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 8 (Day 98)	—	—	180 µg/mL Geometric Coefficient of Variation 42.1	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 6 (Day 105)	—	18.3 µg/mL Geometric Coefficient of Variation 40.8	—	99.7 µg/mL Geometric Coefficient of Variation 53.9	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 9 (Day 112)	—	—	145 µg/mL Geometric Coefficient of Variation 44.7	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 8 (Day 147)	—	20.6 µg/mL Geometric Coefficient of Variation 46.2	—	118 µg/mL Geometric Coefficient of Variation 51.3	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 12 (Day 154)	—	—	206 µg/mL Geometric Coefficient of Variation 42.6	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 9 (Day 168)	168 µg/mL Geometric Coefficient of Variation 26.3	—	—	96.8 µg/mL Geometric Coefficient of Variation 47.2	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 16 (Day 210)	—	—	205 µg/mL Geometric Coefficient of Variation 46	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 12 (Day 231)	—	20.0 µg/mL Geometric Coefficient of Variation 60.1	—	125 µg/mL Geometric Coefficient of Variation 41.3	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 18 (Day 238)	—	—	214 µg/mL Geometric Coefficient of Variation 34.7	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 13 (Day 252)	197 µg/mL Geometric Coefficient of Variation 47.1	—	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 20 (Day 266)	—	—	215 µg/mL Geometric Coefficient of Variation 0.98	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 14 (Day 273)	—	—	—	121 µg/mL Geometric Coefficient of Variation 56.6	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 22 (Day 294)	—	—	209 µg/mL Geometric Coefficient of Variation 17.9	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 2 (Day 14)	—	—	55.0 µg/mL Geometric Coefficient of Variation 33.8	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 3 (Day 28)	—	—	89.3 µg/mL Geometric Coefficient of Variation 39.4	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 3 (Day 42)	—	11.8 µg/mL Geometric Coefficient of Variation 62.1	—	67.9 µg/mL Geometric Coefficient of Variation 45.5	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 4 (Day 42)	—	—	173 µg/mL Geometric Coefficient of Variation 36.3	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 6 (Day 70)	—	—	149 µg/mL Geometric Coefficient of Variation 40.6	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 5 (Day 84)	136 µg/mL Geometric Coefficient of Variation 29.6	—	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 7 (Day 84)	—	—	159 µg/mL Geometric Coefficient of Variation 19.5	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 16 (Day 315)	—	23.3 µg/mL Geometric Coefficient of Variation 29.1	—	124 µg/mL Geometric Coefficient of Variation 48.6	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 24 (Day 322)	—	—	234 µg/mL Geometric Coefficient of Variation 33.5	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 17 (Day 336)	184 µg/mL Geometric Coefficient of Variation 34.8	—	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 26 (Day 350)	—	—	202 µg/mL Geometric Coefficient of Variation 13.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 18 (Day 357)	—	—	—	105 µg/mL Geometric Coefficient of Variation 48.6	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 28 (Day 378)	—	—	140 µg/mL Geometric Coefficient of Variation 33.5	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 20 (Day 399)	—	—	—	81.9 µg/mL Geometric Coefficient of Variation 74.5	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 30 (Day 406)	—	—	149 µg/mL Geometric Coefficient of Variation 16.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 21 (Day 420)	167 µg/mL Geometric Coefficient of Variation 40.2	—	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 32 (Day 434)	—	—	244 µg/mL Geometric Coefficient of Variation 47.7	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 24 (Day 483)	—	24.3 µg/mL Geometric Coefficient of Variation 26	—	137 µg/mL Geometric Coefficient of Variation 43.4	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 36 (Day 490)	—	—	221 µg/mL Geometric Coefficient of Variation 39.9	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 40 (Day 546)	—	—	219 µg/mL Geometric Coefficient of Variation 52.2	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 29 (Day 588)	173 µg/mL Geometric Coefficient of Variation 39.0	32.9 µg/mL Geometric Coefficient of Variation 13.2	—	—	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 32 (Day 651)	—	30.5 µg/mL Geometric Coefficient of Variation 11.6	—	141 µg/mL Geometric Coefficient of Variation 49.8	—	—	—	—	—	—	—	—
Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) Cycle 48 (Day 658)	—	—	206 µg/mL Geometric Coefficient of Variation 111.2	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015)

Population: Melanoma participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.

The percent change from baseline in tumor size based on IRC per RECIST 1.1 was reported according to PD-L1 status in Ipi-Exposed and Ipi-Naïve melanoma participants. Tumor PD-L1 status was measured by the tumor proportion score (TPS), which was the percentage of tumor cells identified using IHC analysis that expressed PD-L1. Tumors with ≥1% positive staining for PD-L1 were considered positive. Maximum tumor change was defined as the percent change of the participant's smallest post-baseline tumor size from the baseline. The number of participants in a percent change from baseline range was reported categorically according to PD-L1 status (PD-L1-Positive, PD-L1 Negative, PD-L1 Status Unknown). Negative percent change from baseline values indicate tumor size reduction, with the greatest reduction possible indicated as "≤ -30%". As specified by the protocol, this analysis of melanoma participants was performed according to ipilimumab exposure (Ipi-Exposed and Ipi-Naïve).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=176 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=37 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=47 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=260 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=140 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=50 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=251 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to Programmed Death-Ligand 1 (PD-L1) Immunohistochemical (IHC) Expression Status in Ipilimumab (Ipi)-Exposed and Ipi-Naive Melanoma Participants (Parts B Plus D) Number of Participants with ≤ -30% CFB	93 Participants	8 Participants	25 Participants	126 Participants	94 Participants	22 Participants	35 Participants	151 Participants	—	—	—	—
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to Programmed Death-Ligand 1 (PD-L1) Immunohistochemical (IHC) Expression Status in Ipilimumab (Ipi)-Exposed and Ipi-Naive Melanoma Participants (Parts B Plus D) Number of Participants with > -30% to <20% CFB	57 Participants	17 Participants	14 Participants	88 Participants	32 Participants	10 Participants	11 Participants	53 Participants	—	—	—	—
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to Programmed Death-Ligand 1 (PD-L1) Immunohistochemical (IHC) Expression Status in Ipilimumab (Ipi)-Exposed and Ipi-Naive Melanoma Participants (Parts B Plus D) Number of Participants with ≥ 20% CFB	26 Participants	12 Participants	8 Participants	46 Participants	14 Participants	18 Participants	15 Participants	47 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015)

Population: NSCLC participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.

Percent CFB in tumor size based on IRC per RECIST 1.1 was reported according to PD-L1 status in prior treatment-naïve and previously-treated NSCLC participants. Tumor PD-L1 status was measured by TPS, which was the percentage of tumor cells identified using IHC analysis that expressed PD-L1, as follows: TPS ≥50% =tumor strongly positive, TPS of 1%-49% =tumor weakly positive, TPS \<1% =tumor considered negative, or TPS unknown. Maximum tumor change for a participant was defined as the percent change of the participant's smallest post-baseline tumor size from baseline. The number of participants in a percent CFB range was reported categorically according to PD-L1 status (TPS ≥50%, TPS = 1-49%, TPS \<1%, TPS Unknown). Negative percent CFB values indicate tumor size reduction, with the greatest reduction possible indicated as "≤ -30%". As specified by the protocol, analysis of NSCLC participants was performed according to prior treatment exposure (Treatment Naive and Previously Treated).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=23 Participants During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=39 Participants During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 Participants During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=9 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=81 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=110 Participants During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=137 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=66 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=38 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=351 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to PD-L1 IHC Expression Status in Prior Treatment (TRT)-Naïve and Previously-Treated NSCLC Participants (Parts C Plus F) Number of Participants with > -30% to <20% CFB	7 Participants	20 Participants	6 Participants	4 Participants	37 Participants	32 Participants	65 Participants	38 Participants	14 Participants	149 Participants	—	—
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to PD-L1 IHC Expression Status in Prior Treatment (TRT)-Naïve and Previously-Treated NSCLC Participants (Parts C Plus F) Number of Participants with ≥ 20% CFB	0 Participants	4 Participants	2 Participants	1 Participants	7 Participants	20 Participants	30 Participants	13 Participants	10 Participants	73 Participants	—	—
Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to PD-L1 IHC Expression Status in Prior Treatment (TRT)-Naïve and Previously-Treated NSCLC Participants (Parts C Plus F) Number of Participants with ≤ -30% CFB	16 Participants	15 Participants	2 Participants	4 Participants	37 Participants	58 Participants	42 Participants	15 Participants	14 Participants	129 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD\]). The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by IRO was reported as the DCR for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Disease Control Rate (DCR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D)	—	—	—	—	—	—	48.1 Percentage of Participants Interval 40.2 to 56.1	47.6 Percentage of Participants Interval 42.0 to 53.3	56.1 Percentage of Participants Interval 48.5 to 63.5	—	—	—

SECONDARY outcome

Timeframe: From time of first documented evidence of CR or PR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)

Population: All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on IRO with confirmation. The DOR according to RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=49 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=92 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=66 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Duration of Response (DOR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D)	—	—	—	—	—	—	NA Weeks NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)	NA Weeks NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)	NA Weeks Interval 16.1 to NA=Median DOR and DOR range upper limit not reached (no progressive disease by time of last disease assessment)	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS according to RECIST 1.1 as assessed by IRO was reported for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	4.9 Months Interval 2.8 to 8.3	3.7 Months Interval 2.8 to 5.5	5.6 Months Interval 3.3 to 10.0	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. OS was reported for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Overall Survival (OS) in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	23.1 Months Interval 17.8 to 33.1	22.5 Months Interval 18.5 to 32.0	26.8 Months Interval 19.6 to 41.8	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

DCR according to irRC was defined as the percentage of participants who had a irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions), irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation), or SD (neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for PD \[at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented\]). The percentage of participants who experienced a confirmed CR, PR, or SD according to irRC as assessed by the investigator was reported as the DCR for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DCR According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	62.3 Percentage of Participants Interval 54.4 to 69.8	62.6 Percentage of Participants Interval 57.0 to 68.0	69.4 Percentage of Participants Interval 62.2 to 76.1	—	—	—

SECONDARY outcome

Timeframe: From time of first documented evidence of iCR or iPR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)

Population: All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment and who demonstrated a confirmed irRC response (irCR or irPR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.

For participants who demonstrated a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC, DOR was defined as the time from first documented evidence of an irCR or irPR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. The DOR according to irRC as assessed by the investigator for all participants who experienced a confirmed irCR or irPR was reported for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=57 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=125 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=82 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DOR According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	NA Months Interval 2.1 to NA=Median DOR and DOR range upper limit not reached (no progressive disease by time of last disease assessment)	NA Months NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)	NA Months Interval 2.7 to NA=Median DOR and DOR range upper limit not reached (no progressive disease by time of last disease assessment)	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. PFS according to irRC as assessed by the investigator was reported for each melanoma dose arm (Parts B plus D).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
PFS According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)	—	—	—	—	—	—	8.2 Months Interval 5.6 to 13.6	6.6 Months Interval 5.5 to 10.5	9.6 Months Interval 5.6 to 19.3	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD\]). The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by IRC was reported as the DCR for each NSCLC dose arm (Parts C plus F).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DCR According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	50.8 Percentage of Participants Interval 37.7 to 63.9	51.6 Percentage of Participants Interval 45.6 to 57.5	49.0 Percentage of Participants Interval 41.9 to 56.1

SECONDARY outcome

Timeframe: From time of first documented evidence of CR or PR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)

Population: All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B and D) participants were analyzed and presented separately and are not included in this analysis.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on IRC with confirmation. The DOR according to RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported for each NSCLC dose arm (Parts C plus F).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=12 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=62 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=39 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DOR According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	NA Months Interval to 19.0 NA=Median DOR and DOR range lower limit not reached (no progressive disease by time of last disease assessment)	NA Months NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)	20.7 Months Interval 2.8 to NA=DOR range upper limit not reached (no progressive disease by time of last disease assessment)

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS according to RECIST 1.1 as assessed by IRC was reported for each NSCLC dose arm (Parts C plus F).

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
PFS According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	3.3 Months Interval 2.0 to 4.4	3.7 Months Interval 2.4 to 4.2	3.4 Months Interval 2.3 to 4.2

SECONDARY outcome

Timeframe: Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
OS in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	8.9 Months Interval 5.8 to 15.4	13.1 Months Interval 10.3 to 17.3	13.4 Months Interval 9.4 to 15.7

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DCR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	57.4 Percentage of Participants Interval 44.1 to 70.1	62.7 Percentage of Participants Interval 56.8 to 68.3	65.3 Percentage of Participants Interval 58.3 to 71.9

SECONDARY outcome

Timeframe: From time of first documented evidence of iCR or iPR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=14 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=83 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=45 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
DOR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	NA Months Interval to 21.9 NA= Median DOR and DOR range lower limit not reached (no progressive disease by time of last disease assessment)	NA Months NA= Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)	NA Months Interval 3.0 to NA=Median DOR and DOR range upper limit not reached (no progressive disease by time of last disease assessment)

SECONDARY outcome

Timeframe: Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)

Outcome measures

Outcome measures
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg every 3 weeks (Q3W) starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 Participants Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 Participants Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
PFS According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)	—	—	—	—	—	—	—	—	—	4.3 Months Interval 2.3 to 6.1	4.4 Months Interval 4.0 to 6.2	5.6 Months Interval 4.1 to 6.5

Adverse Events

Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 6 deaths

Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D)

Serious events: 69 serious events

Other events: 158 other events

Deaths: 111 deaths

MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D)

Serious events: 129 serious events

Other events: 303 other events

Deaths: 213 deaths

MEL: Pembrolizumab 10 mg/kg Q2W (Part B)

Serious events: 79 serious events

Other events: 175 other events

Deaths: 110 deaths

NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F)

Serious events: 34 serious events

Other events: 55 other events

Deaths: 52 deaths

NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F)

Serious events: 119 serious events

Other events: 271 other events

Deaths: 240 deaths

NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F)

Serious events: 86 serious events

Other events: 191 other events

Deaths: 166 deaths

Serious adverse events

Serious adverse events
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 participants at risk During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 participants at risk During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 participants at risk During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=6 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 participants at risk Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 participants at risk Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Pancytopenia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Splenic infarction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Acute coronary syndrome	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Acute myocardial infarction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Angina pectoris	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Angina unstable	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 6/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Atrial flutter	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Atrial thrombosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Cardiac arrest	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Cardiac failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Cardiac failure congestive	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Cardiac tamponade	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Cardio-respiratory arrest	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Coronary artery disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Left ventricular failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Myocardial infarction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Pericardial effusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Pericarditis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Right ventricular failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Supraventricular tachycardia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Tachycardia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Ventricular fibrillation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Ventricular tachycardia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Adrenal haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Hyperthyroidism	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Hypophysitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Hypothyroidism	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Eye disorders Uveitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Eye disorders Visual acuity reduced	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Abdominal mass	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Ascites	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Colitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 6/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Colitis microscopic	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Constipation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Enterocolitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Erosive duodenitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Ileus	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Faecalith	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastric perforation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastritis erosive	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Haematochezia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Inguinal hernia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intestinal mass	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intestinal perforation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intussusception	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Nausea	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Oesophagitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Pancreatic cyst	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Proctalgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Asthenia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Chest pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Chills	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Death	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Drug withdrawal syndrome	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Fatigue	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Gait disturbance	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders General physical health deterioration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Generalised oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Impaired healing	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Inflammation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Influenza like illness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Malaise	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Non-cardiac chest pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Pyrexia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Bile duct stone	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Hepatic failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Arthritis bacterial	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Bacillus bacteraemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Bacterial sepsis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Bronchitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Catheter site infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Cellulitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Chorioretinitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Clostridium difficile colitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Clostridium difficile infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Diverticulitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Enterocolitis infectious	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Erysipelas	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Extradural abscess	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Gastroenteritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Herpes zoster	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Infectious pleural effusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Influenza	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Intervertebral discitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Localised infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lung infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lyme disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lymphangitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Meningitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Meningitis aseptic	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Oesophageal candidiasis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Osteomyelitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pelvic infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pleural infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pneumonia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 5/162 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.4% 8/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.8% 6/61 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 13/202 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pneumonia bacterial	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pneumonia cryptococcal	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pneumonia viral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Post procedural infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Respiratory tract infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Sepsis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Septic shock	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Sinusitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Skin infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Staphylococcal bacteraemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Thrombophlebitis septic	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Tuberculosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Ureteritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Urosepsis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Viral infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Wound infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Back injury	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Hip fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Radius fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Rib fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Wound decomposition	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Blood bilirubin increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Electrocardiogram change	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Medical observation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Cachexia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Failure to thrive	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Fluid overload	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Insulin resistant diabetes	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Malnutrition	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 5/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Ataxia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Brain oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Brain stem infarction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Carotid artery stenosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Depressed level of consciousness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Dizziness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Dysarthria	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Embolic stroke	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Encephalopathy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Epilepsy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Headache	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Ischaemic stroke	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Lethargy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Migraine	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Myasthenia gravis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Neuralgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Partial seizures	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Peripheral paralysis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Presyncope	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Sciatica	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Seizure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Spinal cord compression	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Syncope	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Transient ischaemic attack	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Vasogenic cerebral oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Anxiety	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Completed suicide	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Confusional state	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Mental status changes	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Calculus urinary	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Dysuria	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Nephritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Nephrolithiasis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Renal failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Renal infarct	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urethral haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urethral stenosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urge incontinence	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urinary retention	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Reproductive system and breast disorders Metrorrhagia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Reproductive system and breast disorders Prostatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Diffuse alveolar damage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 5/162 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 7/313 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 9/287 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 14/287 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 8/287 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary vasculitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Embolism	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Hypotension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Peripheral ischaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Shock haemorrhagic	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Superior vena cava occlusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Superior vena cava syndrome	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Vasculitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Vena cava thrombosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Mitral valve prolapse	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Obstruction gastric	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Oedema peripheral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Bile duct obstruction	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Hepatobiliary disorders Hepatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Abdominal abscess	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Disseminated cryptococcosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Herpes simplex encephalitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Listeriosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lymph gland infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Meningitis listeria	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Ejection fraction decreased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Eosinophilic fasciitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Dyskinesia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Hydrocephalus	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Orthostatic hypotension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown

Other adverse events

Other adverse events
Measure	Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) n=4 participants at risk During Cycle 1 participants received a dose of 1 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 1 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) n=3 participants at risk During Cycle 1 participants received a dose of 3 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 3 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) n=10 participants at risk During Cycle 1 participants received a dose of 10 mg/kg pembrolizumab IV infusion over 30 minutes on Day 1 of a 28-day cycle for evaluation of dose-limiting toxicities and pharmacokinetics. Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) n=4 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.005 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) n=3 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.02 mg/kg to 0.3 mg/kg to 2.0 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 2 mg/kg Q3W starting with Cycle 2.	Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) n=6 participants at risk During Cycle 1 participants received pembrolizumab dose titration from 0.06 mg/kg to 1.0 mg/kg to 10 mg/kg on Days 1, 8, and 22, administered as an IV infusion over 30 minutes. Participants received 10 mg/kg Q3W starting with Cycle 2.	MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) n=162 participants at risk Participants received pembrolizumab IV at a dose of 2 mg/kg Q2W. After Amendment 3, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) n=313 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 7, participants received dosing Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	MEL: Pembrolizumab 10 mg/kg Q2W (Part B) n=180 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) n=61 participants at risk Participants received pembrolizumab IV at a dose of 2 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) n=287 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q3W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.	NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) n=202 participants at risk Participants received pembrolizumab IV at a dose of 10 mg/kg Q2W. After Amendment 10, all remaining and ongoing participants were treated with a 200 mg fixed dose of pembrolizumab IV Q3W based on analysis of safety and efficacy data.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 27/162 • Number of events 58 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	19.5% 61/313 • Number of events 113 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 30/180 • Number of events 57 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.9% 37/287 • Number of events 52 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	18.8% 38/202 • Number of events 72 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 7/313 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Cardiac disorders Bradycardia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Endocrine disorders Hypothyroidism	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 16/162 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 23/313 • Number of events 25 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.6% 28/180 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.8% 6/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.0% 20/287 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.9% 22/202 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Eye disorders Dry eye	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Eye disorders Vision blurred	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 21/313 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Eye disorders Visual impairment	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 13/313 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.0% 26/162 • Number of events 40 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.1% 38/313 • Number of events 49 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	17.2% 31/180 • Number of events 55 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.1% 29/287 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 20/202 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.0% 22/313 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Constipation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.0% 2/10 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	27.8% 45/162 • Number of events 60 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	21.7% 68/313 • Number of events 85 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	22.8% 41/180 • Number of events 65 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.4% 10/61 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.4% 47/287 • Number of events 51 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	22.8% 46/202 • Number of events 56 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 2/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 54/162 • Number of events 112 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	35.5% 111/313 • Number of events 195 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	38.9% 70/180 • Number of events 145 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	19.7% 12/61 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	23.3% 67/287 • Number of events 127 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	19.3% 39/202 • Number of events 62 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 23/313 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 18/180 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 12/287 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 10/202 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 11/313 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastritis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.3% 15/162 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 17/287 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Inguinal hernia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Intussusception	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Nausea	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 2/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.0% 2/10 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 2/6 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	34.6% 56/162 • Number of events 91 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	34.5% 108/313 • Number of events 144 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	38.3% 69/180 • Number of events 109 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.8% 9/61 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.9% 60/287 • Number of events 79 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	23.3% 47/202 • Number of events 60 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Oral pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 6/313 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.4% 33/162 • Number of events 50 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	19.8% 62/313 • Number of events 84 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	23.9% 43/180 • Number of events 56 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.8% 9/61 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.3% 44/287 • Number of events 59 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.9% 28/202 • Number of events 53 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Asthenia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.3% 20/162 • Number of events 41 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.0% 50/313 • Number of events 82 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.6% 28/180 • Number of events 72 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.5% 7/61 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.4% 24/287 • Number of events 44 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.4% 23/202 • Number of events 46 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Chest pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 19/313 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 12/180 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.7% 22/287 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 20/202 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Chills	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.5% 17/162 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.7% 43/313 • Number of events 60 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.3% 24/180 • Number of events 28 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 12/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 12/202 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Early satiety	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Face oedema	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	50.0% 5/10 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 2/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	50.0% 3/6 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	47.5% 77/162 • Number of events 157 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	52.1% 163/313 • Number of events 249 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	58.9% 106/180 • Number of events 220 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	27.9% 17/61 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	42.5% 122/287 • Number of events 172 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	38.6% 78/202 • Number of events 110 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Gait disturbance	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Impaired healing	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Influenza like illness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.0% 25/313 • Number of events 27 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Oedema peripheral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	17.3% 28/162 • Number of events 35 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.9% 53/313 • Number of events 68 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.6% 37/180 • Number of events 48 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.2% 38/287 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.4% 23/202 • Number of events 27 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 14/313 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.4% 24/287 • Number of events 27 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 20/202 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Pyrexia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 16/162 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.0% 50/313 • Number of events 72 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	21.1% 38/180 • Number of events 53 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.5% 36/287 • Number of events 63 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.9% 24/202 • Number of events 29 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Secretion discharge	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
General disorders Swelling	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Bronchitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Lung infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Nasopharyngitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.0% 26/162 • Number of events 43 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 31/313 • Number of events 45 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.4% 26/180 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 8/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Oral candidiasis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Oral herpes	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Otitis externa	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Pneumonia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.3% 18/287 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 11/202 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Rhinitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 4/180 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Sinusitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 13/313 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.6% 19/180 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.2% 23/162 • Number of events 49 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.9% 28/313 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.6% 28/180 • Number of events 48 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.8% 34/287 • Number of events 66 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.4% 25/202 • Number of events 32 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 16/162 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.0% 25/313 • Number of events 43 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.1% 20/180 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 16/287 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 11/202 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Back injury	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.64% 2/313 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 12/313 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 9/180 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 10/202 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Injury, poisoning and procedural complications Urostomy complication	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Alanine aminotransferase increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.4% 12/162 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.6% 30/313 • Number of events 38 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.7% 21/180 • Number of events 30 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 16/287 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 11/202 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.5% 33/313 • Number of events 53 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.8% 23/180 • Number of events 36 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 21/287 • Number of events 25 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 13/202 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.1% 16/313 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 14/287 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 9/202 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Blood cholesterol increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.1% 16/313 • Number of events 33 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 9/287 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Blood creatinine increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 14/313 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 12/287 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Weight decreased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 16/162 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.5% 36/313 • Number of events 53 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.1% 26/287 • Number of events 32 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.4% 23/202 • Number of events 25 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Investigations Weight increased	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.8% 11/162 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 17/313 • Number of events 44 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.4% 8/180 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 8/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 10/202 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	30.0% 3/10 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 4/6 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	22.2% 36/162 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	22.4% 70/313 • Number of events 92 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	26.1% 47/180 • Number of events 59 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.4% 10/61 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	30.7% 88/287 • Number of events 125 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	27.2% 55/202 • Number of events 62 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 13/313 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 14/287 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 19/313 • Number of events 60 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 42 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.0% 23/287 • Number of events 41 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.9% 16/202 • Number of events 50 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 17/313 • Number of events 48 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 12/180 • Number of events 25 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 8/287 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 17/313 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 13/287 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 5/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.8% 15/313 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.9% 16/180 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 17/287 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 12/202 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 20/313 • Number of events 38 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 16/287 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 13/202 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 8/162 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.8% 18/313 • Number of events 30 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.2% 22/180 • Number of events 36 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 16/287 • Number of events 28 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.9% 16/202 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.8% 15/313 • Number of events 29 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.4% 8/180 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Iron deficiency	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	30.9% 50/162 • Number of events 103 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	29.7% 93/313 • Number of events 175 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 60/180 • Number of events 128 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.8% 9/61 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	18.8% 54/287 • Number of events 89 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	23.3% 47/202 • Number of events 82 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 2/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	21.6% 35/162 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.9% 53/313 • Number of events 74 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	17.8% 32/180 • Number of events 43 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.5% 36/287 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.9% 28/202 • Number of events 38 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.8% 18/313 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.8% 11/162 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 13/313 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.8% 14/180 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 7/202 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 16/162 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 19/313 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.3% 15/180 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 11/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 17/313 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 21/287 • Number of events 30 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 13/202 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.1% 18/162 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.3% 29/313 • Number of events 33 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.4% 17/180 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.5% 7/61 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.4% 24/287 • Number of events 29 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.4% 17/202 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.3% 7/162 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.2% 23/162 • Number of events 38 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.3% 48/313 • Number of events 68 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 45/180 • Number of events 85 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.0% 23/287 • Number of events 35 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.9% 24/202 • Number of events 28 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 8/162 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.1% 16/313 • Number of events 18 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.4% 11/202 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	18.5% 30/162 • Number of events 45 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	12.8% 40/313 • Number of events 58 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	17.8% 32/180 • Number of events 47 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 21/287 • Number of events 29 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 12/202 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.2% 7/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 6/180 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Dizziness	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.0% 21/162 • Number of events 34 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.9% 34/313 • Number of events 46 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.4% 26/180 • Number of events 34 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.9% 40/287 • Number of events 52 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 20/202 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 5/162 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 11/313 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 6/180 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 11/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Headache	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	22.2% 36/162 • Number of events 58 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.2% 79/313 • Number of events 127 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	28.9% 52/180 • Number of events 91 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.2% 5/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.3% 41/287 • Number of events 46 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.4% 19/202 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 9/180 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.4% 4/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Memory impairment	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 14/313 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 14/287 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Paraesthesia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 19/313 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.2% 13/180 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 9/202 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Sciatica	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.0% 3/287 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.0% 4/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Anxiety	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.7% 24/313 • Number of events 27 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.3% 15/180 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 17/287 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.9% 12/202 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Depressed mood	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Depression	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 2/6 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 12/180 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.4% 7/287 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.9% 14/202 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Psychiatric disorders Insomnia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	17.9% 29/162 • Number of events 39 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.5% 36/313 • Number of events 41 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.6% 19/180 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.1% 32/287 • Number of events 34 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.9% 16/202 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Renal and urinary disorders Urinary tract obstruction	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Reproductive system and breast disorders Breast pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 5/313 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Reproductive system and breast disorders Nipple pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.32% 1/313 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.0% 2/10 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	31.5% 51/162 • Number of events 81 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	29.4% 92/313 • Number of events 151 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	32.2% 58/180 • Number of events 92 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.4% 10/61 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	30.0% 86/287 • Number of events 127 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.2% 51/202 • Number of events 72 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	18.5% 30/162 • Number of events 44 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	20.8% 65/313 • Number of events 85 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	23.3% 42/180 • Number of events 60 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.4% 10/61 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	27.9% 80/287 • Number of events 97 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.7% 52/202 • Number of events 66 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 9/180 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 19/287 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 10/202 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 21/287 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.4% 15/202 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.4% 12/162 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.6% 27/313 • Number of events 42 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 18/180 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 11/287 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.5% 9/202 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.3% 23/313 • Number of events 33 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.8% 14/180 • Number of events 26 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 12/287 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.3% 4/313 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.8% 6/61 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.2% 15/287 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.4% 15/202 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.1% 2/180 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 12/313 • Number of events 17 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 14 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 12/287 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.1% 18/162 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.4% 20/313 • Number of events 30 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 12/180 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.0% 20/287 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.9% 22/202 • Number of events 27 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.62% 1/162 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.96% 3/313 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.56% 1/180 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 9/287 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.8% 11/162 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.6% 27/313 • Number of events 32 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.7% 12/180 • Number of events 15 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 3/61 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 19/287 • Number of events 24 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.4% 21/202 • Number of events 25 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.2% 10/162 • Number of events 13 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.8% 18/313 • Number of events 22 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.5% 10/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.6% 8/313 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 10/180 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.3% 15/162 • Number of events 20 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.8% 18/313 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	8.3% 15/180 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.70% 2/287 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Pruritus	75.0% 3/4 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	66.7% 2/3 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	30.2% 49/162 • Number of events 92 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	31.6% 99/313 • Number of events 165 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	36.7% 66/180 • Number of events 121 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.6% 4/61 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	18.1% 52/287 • Number of events 73 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.4% 27/202 • Number of events 36 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.9% 9/313 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.9% 7/180 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	33.3% 1/3 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	29.0% 47/162 • Number of events 84 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	27.8% 87/313 • Number of events 189 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	25.0% 45/180 • Number of events 103 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	11.5% 7/61 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.0% 43/287 • Number of events 71 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.4% 27/202 • Number of events 42 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.9% 8/162 • Number of events 10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	7.0% 22/313 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 6/180 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.1% 9/287 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.2% 10/313 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 3/180 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.50% 1/202 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Skin induration	25.0% 1/4 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/162 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	13.0% 21/162 • Number of events 33 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	14.1% 44/313 • Number of events 57 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	15.6% 28/180 • Number of events 37 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/287 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/202 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Hot flush	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.6% 9/162 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 6/313 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 7 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.5% 3/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Hypertension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 4/162 • Number of events 8 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	9.9% 31/313 • Number of events 87 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	6.1% 11/180 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.3% 2/61 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.8% 11/287 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 11 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Vascular disorders Hypotension	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.9% 3/162 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.1% 16/313 • Number of events 21 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.7% 5/287 • Number of events 6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.5% 5/202 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.7% 6/162 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.1% 16/313 • Number of events 19 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	5.0% 9/180 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.1% 6/287 • Number of events 12 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	3.0% 6/202 • Number of events 23 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Nervous system disorders Cognitive disorder	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/10 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	16.7% 1/6 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/313 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/180 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/61 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.35% 1/287 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.99% 2/202 • Number of events 3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	10.0% 1/10 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/4 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/3 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	0.00% 0/6 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.2% 2/162 • Number of events 2 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.2% 13/313 • Number of events 16 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 5/180 • Number of events 5 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	1.6% 1/61 • Number of events 1 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	2.8% 8/287 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown	4.0% 8/202 • Number of events 9 • Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) All-Cause Mortality reported for all randomized/enrolled participants. AEs reported for All Treated Population.Per protocol, disease progression on study not considered an AE unless related to drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. 5 participants were not assessed by cutoff and were followed to study completion; end of study assessments are missing for these 5 and status is unknown

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER