Trial Outcomes & Findings for Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (NCT NCT02720068)

NCT ID: NCT02720068

Last Updated: 2025-05-30

Results Overview

DLTs were assessed during the first cycle (21 days) \& were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for \>1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 481 participants
• Primary outcome timeframe: Up to 21 days (Cycle 1)
• Results posted on: 2025-05-30

Participant Flow

One participant received 2 randomization numbers due to an erroneous initial randomization, but is only counted once in Participant Flow due to the rapid correction and drug administration only happening after the correction.

Participant milestones

Measure	Part A: Favezelimab 7 mg Monotherapy Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Overall Study STARTED	3	6	3	3	3	3	3	3	3	3	21	206	40	41	59	20	21	40
Overall Study Treated	3	6	3	3	3	3	3	3	3	3	20	205	40	41	58	20	20	40
Overall Study Switched Over to Favezelimab + Pembrolizumab	0	0	0	0	0	0	0	0	0	0	9	0	0	0	0	0	0	0
Overall Study Received Second Course of Treatment	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	6	3	3	3	3	3	3	3	3	21	206	40	41	59	20	21	40

Reasons for withdrawal

Measure	Part A: Favezelimab 7 mg Monotherapy Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study Death	1	3	2	1	2	1	2	2	3	1	20	166	34	30	45	16	20	28
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	1	0	1	2	0	0	1
Overall Study Physician Decision	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	1
Overall Study Progressive Disease	2	3	1	1	1	2	1	1	0	1	0	4	1	0	0	0	0	0
Overall Study Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	6	3	2	4	4	0	8
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	1	0	27	2	8	7	0	0	2
Overall Study Protocol Violation	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0

Baseline Characteristics

Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

Baseline characteristics by cohort

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=21 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=206 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=40 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: MK-4280A (Arm 5) n=59 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=21 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=40 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Total n=481 Participants Total of all reporting groups
Age, Continuous	56.3 Years STANDARD_DEVIATION 15.5 • n=5 Participants	59.3 Years STANDARD_DEVIATION 10.1 • n=7 Participants	68.7 Years STANDARD_DEVIATION 15.3 • n=5 Participants	48.7 Years STANDARD_DEVIATION 6.1 • n=4 Participants	52.0 Years STANDARD_DEVIATION 14.7 • n=21 Participants	54.0 Years STANDARD_DEVIATION 12.2 • n=8 Participants	52.3 Years STANDARD_DEVIATION 17.1 • n=8 Participants	64.7 Years STANDARD_DEVIATION 7.5 • n=24 Participants	55.3 Years STANDARD_DEVIATION 12.4 • n=42 Participants	68.7 Years STANDARD_DEVIATION 9.6 • n=42 Participants	60.3 Years STANDARD_DEVIATION 10.6 • n=42 Participants	58.1 Years STANDARD_DEVIATION 11.2 • n=42 Participants	58.5 Years STANDARD_DEVIATION 12.0 • n=36 Participants	57.9 Years STANDARD_DEVIATION 10.9 • n=36 Participants	56.3 Years STANDARD_DEVIATION 9.7 • n=24 Participants	58.3 Years STANDARD_DEVIATION 12.1 • n=135 Participants	59.5 Years STANDARD_DEVIATION 9.9 • n=136 Participants	61.1 Years STANDARD_DEVIATION 11.0 • n=44 Participants	58.3 Years STANDARD_DEVIATION 11.05 • n=667 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants	73 Participants n=42 Participants	15 Participants n=36 Participants	17 Participants n=36 Participants	11 Participants n=24 Participants	5 Participants n=135 Participants	9 Participants n=136 Participants	21 Participants n=44 Participants	180 Participants n=667 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	10 Participants n=42 Participants	133 Participants n=42 Participants	25 Participants n=36 Participants	24 Participants n=36 Participants	48 Participants n=24 Participants	15 Participants n=135 Participants	12 Participants n=136 Participants	19 Participants n=44 Participants	301 Participants n=667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	25 Participants n=42 Participants	6 Participants n=36 Participants	8 Participants n=36 Participants	4 Participants n=24 Participants	1 Participants n=135 Participants	7 Participants n=136 Participants	1 Participants n=44 Participants	58 Participants n=667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	19 Participants n=42 Participants	174 Participants n=42 Participants	33 Participants n=36 Participants	32 Participants n=36 Participants	52 Participants n=24 Participants	19 Participants n=135 Participants	12 Participants n=136 Participants	39 Participants n=44 Participants	406 Participants n=667 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	3 Participants n=24 Participants	0 Participants n=135 Participants	2 Participants n=136 Participants	0 Participants n=44 Participants	17 Participants n=667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	3 Participants n=667 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	36 Participants n=42 Participants	11 Participants n=36 Participants	9 Participants n=36 Participants	20 Participants n=24 Participants	7 Participants n=135 Participants	2 Participants n=136 Participants	12 Participants n=44 Participants	98 Participants n=667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	3 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	0 Participants n=44 Participants	15 Participants n=667 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	19 Participants n=42 Participants	164 Participants n=42 Participants	29 Participants n=36 Participants	31 Participants n=36 Participants	30 Participants n=24 Participants	12 Participants n=135 Participants	17 Participants n=136 Participants	25 Participants n=44 Participants	356 Participants n=667 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	3 Participants n=667 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	4 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	5 Participants n=667 Participants

PRIMARY outcome

Timeframe: Up to 21 days (Cycle 1)

Population: All participants who received ≥1 dose of study treatment prior to determination of maximum tolerated dose, and were observed for safety for 21 days after their first dose of assigned treatment or experienced a DLT prior to 21 days after their first dose of assigned treatment.

DLTs were assessed during the first cycle (21 days) & were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for >1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=19 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=198 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=38 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=38 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=38 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=39 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 31.3 months

Population: All participants who received ≥1 dose of study treatment

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=20 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=205 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=40 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=58 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=40 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=9 Participants Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=1 Participants One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Number of Participants Who Experienced an Adverse Event (AE)	3 Participants	5 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	19 Participants	196 Participants	40 Participants	41 Participants	20 Participants	20 Participants	55 Participants	40 Participants	7 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 28.3 months

Population: All participants who received ≥1 dose of study treatment

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=20 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=205 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=40 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=58 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=40 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=9 Participants Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=1 Participants One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Number of Participants Who Discontinued Study Treatment Due to an AE	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	22 Participants	5 Participants	2 Participants	6 Participants	0 Participants	5 Participants	11 Participants	1 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 92 months

Population: All participants enrolled in Part B with a baseline scan with measurable disease by investigator assessment, who received ≥1 dose of study treatment

ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=20 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=105 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=60 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=40 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=40 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=41 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=39 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=19 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=20 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=20 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=40 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Objective Response Rate (ORR) for Part B Participants	0.0 Percentage of Participants Interval 0.0 to 16.8	3.8 Percentage of Participants Interval 1.0 to 9.5	15.0 Percentage of Participants Interval 7.1 to 26.6	7.5 Percentage of Participants Interval 1.6 to 20.4	15.0 Percentage of Participants Interval 5.7 to 29.8	7.3 Percentage of Participants Interval 1.5 to 19.9	5.1 Percentage of Participants Interval 0.6 to 17.3	10.5 Percentage of Participants Interval 1.3 to 33.1	25.0 Percentage of Participants Interval 8.7 to 49.1	0.0 Percentage of Participants Interval 0.0 to 16.8	7.5 Percentage of Participants Interval 1.6 to 20.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=6 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=7 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=6 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=187 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=6 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=45 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=184 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=6 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=3 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=3 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=18 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=2 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=188 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=3 Participants Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=40 Participants One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=40 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=33 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) n=54 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab Cycle 1	7.12 Day*μg/mL Geometric Coefficient of Variation 58.8	34.6 Day*μg/mL Geometric Coefficient of Variation 45.4	98.8 Day*μg/mL Geometric Coefficient of Variation 42.7	305 Day*μg/mL Geometric Coefficient of Variation 48.4	365 Day*μg/mL Geometric Coefficient of Variation 39.8	1480 Day*μg/mL Geometric Coefficient of Variation 39.6	1620 Day*μg/mL Geometric Coefficient of Variation 54.7	10.5 Day*μg/mL Geometric Coefficient of Variation 49	37.4 Day*μg/mL Geometric Coefficient of Variation 43.3	99.3 Day*μg/mL Geometric Coefficient of Variation 28.6	341 Day*μg/mL Geometric Coefficient of Variation 51	1590 Day*μg/mL Geometric Coefficient of Variation 21.5	1820 Day*μg/mL Geometric Coefficient of Variation 46.6	4.81 Day*μg/mL Geometric Coefficient of Variation 25.7	21.5 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	98.3 Day*μg/mL Geometric Coefficient of Variation 63.7	305 Day*μg/mL Geometric Coefficient of Variation 48.3	391 Day*μg/mL Geometric Coefficient of Variation 36.1	1610 Day*μg/mL Geometric Coefficient of Variation 36.5	1440 Day*μg/mL Geometric Coefficient of Variation 41.6	1430 Day*μg/mL Geometric Coefficient of Variation 46.4	1670 Day*μg/mL Geometric Coefficient of Variation 40.3	1870 Day*μg/mL Geometric Coefficient of Variation 75.1	2010 Day*μg/mL Geometric Coefficient of Variation 54.5	1430 Day*μg/mL Geometric Coefficient of Variation 49.6
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab Cycle 2	8.28 Day*μg/mL Geometric Coefficient of Variation 45.8	33.1 Day*μg/mL Geometric Coefficient of Variation 41.3	56.0 Day*μg/mL Geometric Coefficient of Variation 179.4	330 Day*μg/mL Geometric Coefficient of Variation 58.1	335 Day*μg/mL Geometric Coefficient of Variation 48.5	1730 Day*μg/mL Geometric Coefficient of Variation 53.1	1850 Day*μg/mL Geometric Coefficient of Variation 59.2	14.6 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	33.1 Day*μg/mL Geometric Coefficient of Variation 41.3	60.0 Day*μg/mL Geometric Coefficient of Variation 92.4	298 Day*μg/mL Geometric Coefficient of Variation 51.6	1640 Day*μg/mL Geometric Coefficient of Variation 20.5	2200 Day*μg/mL Geometric Coefficient of Variation 42.8	6.86 Day*μg/mL Geometric Coefficient of Variation 27.3	—	52.2 Day*μg/mL Geometric Coefficient of Variation 429.4	324 Day*μg/mL Geometric Coefficient of Variation 58.7	378 Day*μg/mL Geometric Coefficient of Variation 53.1	2330 Day*μg/mL Geometric Coefficient of Variation 18.4	1690 Day*μg/mL Geometric Coefficient of Variation 57.4	1450 Day*μg/mL Geometric Coefficient of Variation 49.9	2300 Day*μg/mL Geometric Coefficient of Variation 46.6	—	2690 Day*μg/mL Geometric Coefficient of Variation 55	1580 Day*μg/mL Geometric Coefficient of Variation 61.9
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab Cycle 3	—	—	—	248 Day*μg/mL Geometric Coefficient of Variation 33.6	—	2000 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	3880 Day*μg/mL Geometric Coefficient of Variation 16.9	—	—	—	—	—	3880 Day*μg/mL Geometric Coefficient of Variation 16.8	—	—	—	248 Day*μg/mL Geometric Coefficient of Variation 33.6	—	—	2000 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	—	—	—	—	—
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab Cycle 4	9.38 Day*μg/mL Geometric Coefficient of Variation 22.3	13.7 Day*μg/mL Geometric Coefficient of Variation 79.5	88.2 Day*μg/mL Geometric Coefficient of Variation 80.4	329 Day*μg/mL Geometric Coefficient of Variation 71.5	166 Day*μg/mL Geometric Coefficient of Variation 114.5	1870 Day*μg/mL Geometric Coefficient of Variation 56.5	1860 Day*μg/mL Geometric Coefficient of Variation 58.6	—	—	46.1 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	113 Day*μg/mL Geometric Coefficient of Variation 109.9	—	2880 Day*μg/mL Geometric Coefficient of Variation 55.2	9.38 Day*μg/mL Geometric Coefficient of Variation 22.3	13.7 Day*μg/mL Geometric Coefficient of Variation 79.5	122 Day*μg/mL Geometric Coefficient of Variation 66.4	330 Day*μg/mL Geometric Coefficient of Variation 70.6	357 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	1240 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	1940 Day*μg/mL Geometric Coefficient of Variation 57.5	1570 Day*μg/mL Geometric Coefficient of Variation 40.7	2370 Day*μg/mL Geometric Coefficient of Variation 44.6	—	2070 Day*μg/mL Geometric Coefficient of Variation 73.8	1640 Day*μg/mL Geometric Coefficient of Variation 62.4
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab Cycle 8	—	—	—	—	—	—	2030 Day*μg/mL Geometric Coefficient of Variation 67.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	2030 Day*μg/mL Geometric Coefficient of Variation 67.6

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=6 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=9 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=6 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=191 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=6 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=46 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=188 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=6 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=3 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=3 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=18 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=191 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=3 Participants Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=40 Participants One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=40 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=36 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) n=58 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab Cycle 2	7.83 Day*μg/mL Geometric Coefficient of Variation 73.1	32.7 Day*μg/mL Geometric Coefficient of Variation 40.1	56.4 Day*μg/mL Geometric Coefficient of Variation 154.4	300 Day*μg/mL Geometric Coefficient of Variation 51.4	321 Day*μg/mL Geometric Coefficient of Variation 44.9	1480 Day*μg/mL Geometric Coefficient of Variation 43	1570 Day*μg/mL Geometric Coefficient of Variation 54.9	9.32 Day*μg/mL Geometric Coefficient of Variation 184.6	32.7 Day*μg/mL Geometric Coefficient of Variation 40.1	59.3 Day*μg/mL Geometric Coefficient of Variation 88.6	292 Day*μg/mL Geometric Coefficient of Variation 48.3	1470 Day*μg/mL Geometric Coefficient of Variation 15.7	2140 Day*μg/mL Geometric Coefficient of Variation 40.9	6.97 Day*μg/mL Geometric Coefficient of Variation 25.7	—	53.7 Day*μg/mL Geometric Coefficient of Variation 327.1	300 Day*μg/mL Geometric Coefficient of Variation 51.4	353 Day*μg/mL Geometric Coefficient of Variation 49.8	1640 Day*μg/mL Geometric Coefficient of Variation 38.7	1460 Day*μg/mL Geometric Coefficient of Variation 46	1260 Day*μg/mL Geometric Coefficient of Variation 65.1	1820 Day*μg/mL Geometric Coefficient of Variation 37.2	—	2050 Day*μg/mL Geometric Coefficient of Variation 43.6	1400 Day*μg/mL Geometric Coefficient of Variation 51.9
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab Cycle 1	7.29 Day*μg/mL Geometric Coefficient of Variation 58.4	37.5 Day*μg/mL Geometric Coefficient of Variation 41.1	96.1 Day*μg/mL Geometric Coefficient of Variation 39.6	285 Day*μg/mL Geometric Coefficient of Variation 42.8	353 Day*μg/mL Geometric Coefficient of Variation 38.4	1300 Day*μg/mL Geometric Coefficient of Variation 34.1	1430 Day*μg/mL Geometric Coefficient of Variation 48.1	11.0 Day*μg/mL Geometric Coefficient of Variation 38.6	36.5 Day*μg/mL Geometric Coefficient of Variation 42.4	97.2 Day*μg/mL Geometric Coefficient of Variation 28.5	333 Day*μg/mL Geometric Coefficient of Variation 49.6	1440 Day*μg/mL Geometric Coefficient of Variation 23.2	1550 Day*μg/mL Geometric Coefficient of Variation 35.8	4.82 Day*μg/mL Geometric Coefficient of Variation 28.5	39.6 Day*μg/mL Geometric Coefficient of Variation 47.7	95.0 Day*μg/mL Geometric Coefficient of Variation 57.5	285 Day*μg/mL Geometric Coefficient of Variation 42.8	374 Day*μg/mL Geometric Coefficient of Variation 34.9	1370 Day*μg/mL Geometric Coefficient of Variation 30.0	1290 Day*μg/mL Geometric Coefficient of Variation 35.5	1330 Day*μg/mL Geometric Coefficient of Variation 40.5	1420 Day*μg/mL Geometric Coefficient of Variation 34.8	1640 Day*μg/mL Geometric Coefficient of Variation 71.9	1630 Day*μg/mL Geometric Coefficient of Variation 41.6	1290 Day*μg/mL Geometric Coefficient of Variation 43.7
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab Cycle 3	—	—	—	241 Day*μg/mL Geometric Coefficient of Variation 26.4	—	1770 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	2330 Day*μg/mL Geometric Coefficient of Variation 51.5	—	—	—	—	—	2330 Day*μg/mL Geometric Coefficient of Variation 51.5	—	—	—	241 Day*μg/mL Geometric Coefficient of Variation 26.4	—	—	1770 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	—	—	—	—	—
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab Cycle 4	9.57 Day*μg/mL Geometric Coefficient of Variation 21.9	13.8 Day*μg/mL Geometric Coefficient of Variation 81	89.6 Day*μg/mL Geometric Coefficient of Variation 65	306 Day*μg/mL Geometric Coefficient of Variation 63.4	174 Day*μg/mL Geometric Coefficient of Variation 91	1620 Day*μg/mL Geometric Coefficient of Variation 44.2	1710 Day*μg/mL Geometric Coefficient of Variation 53.6	—	—	53.1 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	124 Day*μg/mL Geometric Coefficient of Variation 83.4	—	2320 Day*μg/mL Geometric Coefficient of Variation 34.6	9.57 Day*μg/mL Geometric Coefficient of Variation 21.9	13.8 Day*μg/mL Geometric Coefficient of Variation 81	116 Day*μg/mL Geometric Coefficient of Variation 58.6	306 Day*μg/mL Geometric Coefficient of Variation 63.4	341 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	1120 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	1670 Day*μg/mL Geometric Coefficient of Variation 44.6	1500 Day*μg/mL Geometric Coefficient of Variation 37.7	2070 Day*μg/mL Geometric Coefficient of Variation 40.4	—	2330 Day*μg/mL Geometric Coefficient of Variation 90.1	1490 Day*μg/mL Geometric Coefficient of Variation 53.7
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab Cycle 8	—	—	—	—	—	—	1730 Day*μg/mL Geometric Coefficient of Variation 51.8	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1730 Day*μg/mL Geometric Coefficient of Variation 51.8

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=6 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=9 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=6 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=203 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=6 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=46 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=195 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=6 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=3 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=3 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=18 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=203 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=3 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=3 Participants Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=40 Participants One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=38 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) n=58 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Maximum Serum Concentration (Cmax) of Favezelimab Cycle 3	—	—	—	19.2 μg/mL Geometric Coefficient of Variation 138.4	—	150 μg/mL Geometric Coefficient of Variation 54	272 μg/mL Geometric Coefficient of Variation 45.6	—	—	—	—	—	272 μg/mL Geometric Coefficient of Variation 45.6	—	—	—	19.2 μg/mL Geometric Coefficient of Variation 138.4	—	—	150 μg/mL Geometric Coefficient of Variation 54	—	—	—	—	—
Maximum Serum Concentration (Cmax) of Favezelimab Cycle 1	2.39 μg/mL Geometric Coefficient of Variation 44.4	8.00 μg/mL Geometric Coefficient of Variation 22	21.9 μg/mL Geometric Coefficient of Variation 34.5	56.7 μg/mL Geometric Coefficient of Variation 32.2	77.4 μg/mL Geometric Coefficient of Variation 29.9	224 μg/mL Geometric Coefficient of Variation 27	248 μg/mL Geometric Coefficient of Variation 27.8	3.16 μg/mL Geometric Coefficient of Variation 44.9	8.62 μg/mL Geometric Coefficient of Variation 17.6	23.7 μg/mL Geometric Coefficient of Variation 21.9	74.9 μg/mL Geometric Coefficient of Variation 28.8	216 μg/mL Geometric Coefficient of Variation 19.9	271 μg/mL Geometric Coefficient of Variation 20.7	1.80 μg/mL Geometric Coefficient of Variation 17.9	6.88 μg/mL Geometric Coefficient of Variation 25.2	20.2 μg/mL Geometric Coefficient of Variation 48.9	56.7 μg/mL Geometric Coefficient of Variation 32.2	80.0 μg/mL Geometric Coefficient of Variation 37.5	252 μg/mL Geometric Coefficient of Variation 46.6	223 μg/mL Geometric Coefficient of Variation 26.5	248 μg/mL Geometric Coefficient of Variation 20.5	219 μg/mL Geometric Coefficient of Variation 23.6	281 μg/mL Geometric Coefficient of Variation 35.7	244 μg/mL Geometric Coefficient of Variation 33.9	234 μg/mL Geometric Coefficient of Variation 24.5
Maximum Serum Concentration (Cmax) of Favezelimab Cycle 2	2.44 μg/mL Geometric Coefficient of Variation 46.5	8.62 μg/mL Geometric Coefficient of Variation 29.2	19.3 μg/mL Geometric Coefficient of Variation 47.1	56.8 μg/mL Geometric Coefficient of Variation 34.9	76.7 μg/mL Geometric Coefficient of Variation 21.1	247 μg/mL Geometric Coefficient of Variation 32	247 μg/mL Geometric Coefficient of Variation 36.6	2.67 μg/mL Geometric Coefficient of Variation 97.4	9.65 μg/mL Geometric Coefficient of Variation 19.6	20.8 μg/mL Geometric Coefficient of Variation 21.8	70.6 μg/mL Geometric Coefficient of Variation 23.3	222 μg/mL Geometric Coefficient of Variation 15.8	301 μg/mL Geometric Coefficient of Variation 18	2.30 μg/mL Geometric Coefficient of Variation 21.4	6.88 μg/mL Geometric Coefficient of Variation 35.3	17.9 μg/mL Geometric Coefficient of Variation 74	56.8 μg/mL Geometric Coefficient of Variation 34.9	83.3 μg/mL Geometric Coefficient of Variation 19.2	238 μg/mL Geometric Coefficient of Variation 58.9	250 μg/mL Geometric Coefficient of Variation 31.5	228 μg/mL Geometric Coefficient of Variation 53.8	245 μg/mL Geometric Coefficient of Variation 25.5	—	266 μg/mL Geometric Coefficient of Variation 35.4	240 μg/mL Geometric Coefficient of Variation 28.6
Maximum Serum Concentration (Cmax) of Favezelimab Cycle 4	3.02 μg/mL Geometric Coefficient of Variation 6.2	6.11 μg/mL Geometric Coefficient of Variation 39.4	27.0 μg/mL Geometric Coefficient of Variation 30.6	58.6 μg/mL Geometric Coefficient of Variation 34.6	54.0 μg/mL Geometric Coefficient of Variation 9.3	253 μg/mL Geometric Coefficient of Variation 35	265 μg/mL Geometric Coefficient of Variation 32.2	—	—	24.5 μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	55.3 μg/mL Geometric Coefficient of Variation 11.8	—	332 μg/mL Geometric Coefficient of Variation 19.4	3.02 μg/mL Geometric Coefficient of Variation 6.3	6.11 μg/mL Geometric Coefficient of Variation 39.4	28.3 μg/mL Geometric Coefficient of Variation 42.5	58.6 μg/mL Geometric Coefficient of Variation 34.6	51.4 μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	145 μg/mL Geometric Coefficient of Variation 37.5	269 μg/mL Geometric Coefficient of Variation 29.4	252 μg/mL Geometric Coefficient of Variation 26.1	267 μg/mL Geometric Coefficient of Variation 35.7	—	262 μg/mL Geometric Coefficient of Variation 34.5	254 μg/mL Geometric Coefficient of Variation 35.9
Maximum Serum Concentration (Cmax) of Favezelimab Cycle 8	—	—	—	—	—	—	292 μg/mL Geometric Coefficient of Variation 26.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	292 μg/mL Geometric Coefficient of Variation 26.6

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=412 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=2 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=197 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=40 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=40 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=20 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=36 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=20 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=54 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
AUC0-inf of Pembrolizumab Cycle 4	903 Day*μg/mL Geometric Coefficient of Variation 49.2	1190 Day*μg/mL Geometric Coefficient of Variation 17	503 Day*μg/mL Geometric Coefficient of Variation 101.3	3650 Day*μg/mL Geometric Coefficient of Variation 181.2	894 Day*μg/mL Geometric Coefficient of Variation 47.9	962 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	528 Day*μg/mL Geometric Coefficient of Variation 43.0	997 Day*μg/mL Geometric Coefficient of Variation 56.6	848 Day*μg/mL Geometric Coefficient of Variation 37.8	1000 Day*μg/mL Geometric Coefficient of Variation 21.6	—	929 Day*μg/mL Geometric Coefficient of Variation 35.7	1040 Day*μg/mL Geometric Coefficient of Variation 73	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-inf of Pembrolizumab Cycle 8	1980 Day*μg/mL Geometric Coefficient of Variation 54.8	—	—	—	—	—	—	—	—	—	—	—	1970 Day*μg/mL Geometric Coefficient of Variation 55	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-inf of Pembrolizumab Cycle 1	586 Day*μg/mL Geometric Coefficient of Variation 38.9	662 Day*μg/mL Geometric Coefficient of Variation 20.7	332 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	612 Day*μg/mL Geometric Coefficient of Variation 40.8	564 Day*μg/mL Geometric Coefficient of Variation 40.8	821 Day*μg/mL Geometric Coefficient of Variation 18.2	543 Day*μg/mL Geometric Coefficient of Variation 27.4	586 Day*μg/mL Geometric Coefficient of Variation 39.1	589 Day*μg/mL Geometric Coefficient of Variation 34.4	626 Day*μg/mL Geometric Coefficient of Variation 26.7	623 Day*μg/mL Geometric Coefficient of Variation 44.6	661 Day*μg/mL Geometric Coefficient of Variation 32.9	619 Day*μg/mL Geometric Coefficient of Variation 41.3	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-inf of Pembrolizumab Cycle 2	843 Day*μg/mL Geometric Coefficient of Variation 52.1	1060 Day*μg/mL Geometric Coefficient of Variation 22.4	613 Day*μg/mL Geometric Coefficient of Variation 100.5	940 Day*μg/mL Geometric Coefficient of Variation 46.3	807 Day*μg/mL Geometric Coefficient of Variation 50.6	727 Day*μg/mL Geometric Coefficient of Variation 67.2	847 Day*μg/mL Geometric Coefficient of Variation 23.2	877 Day*μg/mL Geometric Coefficient of Variation 53.7	812 Day*μg/mL Geometric Coefficient of Variation 41.4	1150 Day*μg/mL Geometric Coefficient of Variation 59.8	—	1100 Day*μg/mL Geometric Coefficient of Variation 48.8	861 Day*μg/mL Geometric Coefficient of Variation 75.4	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-inf of Pembrolizumab Cycle 3	846 Day*μg/mL Geometric Coefficient of Variation 98	—	—	—	878 Day*μg/mL Geometric Coefficient of Variation 72.1	—	—	1990 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=424 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=197 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=40 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=40 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=20 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=38 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=20 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=54 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
AUC0-21 Days of Pembrolizumab Cycle 2	561 Day*μg/mL Geometric Coefficient of Variation 38	615 Day*μg/mL Geometric Coefficient of Variation 16.8	504 Day*μg/mL Geometric Coefficient of Variation 88.8	597 Day*μg/mL Geometric Coefficient of Variation 38.3	545 Day*μg/mL Geometric Coefficient of Variation 36.6	662 Day*μg/mL Geometric Coefficient of Variation 57.6	487 Day*μg/mL Geometric Coefficient of Variation 27.9	588 Day*μg/mL Geometric Coefficient of Variation 35.4	553 Day*μg/mL Geometric Coefficient of Variation 25.1	618 Day*μg/mL Geometric Coefficient of Variation 22.9	—	621 Day*μg/mL Geometric Coefficient of Variation 32.4	547 Day*μg/mL Geometric Coefficient of Variation 56.9	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-21 Days of Pembrolizumab Cycle 3	543 Day*μg/mL Geometric Coefficient of Variation 38.7	—	—	—	537 Day*μg/mL Geometric Coefficient of Variation 40.1	—	—	577 Day*μg/mL Geometric Coefficient of Variation 43.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-21 Days of Pembrolizumab Cycle 4	692 Day*μg/mL Geometric Coefficient of Variation 39.3	805 Day*μg/mL Geometric Coefficient of Variation 5	403 Day*μg/mL Geometric Coefficient of Variation 74.6	1050 Day*μg/mL Geometric Coefficient of Variation 79.9	670 Day*μg/mL Geometric Coefficient of Variation 36.4	701 Day*μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	416 Day*μg/mL Geometric Coefficient of Variation 15.7	754 Day*μg/mL Geometric Coefficient of Variation 45.4	664 Day*μg/mL Geometric Coefficient of Variation 31.9	769 Day*μg/mL Geometric Coefficient of Variation 21.3	—	727 Day*μg/mL Geometric Coefficient of Variation 36.7	705 Day*μg/mL Geometric Coefficient of Variation 45.7	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-21 Days of Pembrolizumab Cycle 1	427 Day*μg/mL Geometric Coefficient of Variation 31.5	418 Day*μg/mL Geometric Coefficient of Variation 13	485 Day*μg/mL Geometric Coefficient of Variation 49	382 Day*μg/mL Geometric Coefficient of Variation 36.7	412 Day*μg/mL Geometric Coefficient of Variation 31.1	556 Day*μg/mL Geometric Coefficient of Variation 15.2	410 Day*μg/mL Geometric Coefficient of Variation 30.0	422 Day*μg/mL Geometric Coefficient of Variation 28.5	427 Day*μg/mL Geometric Coefficient of Variation 25.2	431 Day*μg/mL Geometric Coefficient of Variation 24	489 Day*μg/mL Geometric Coefficient of Variation 39.3	447 Day*μg/mL Geometric Coefficient of Variation 32.8	427 Day*μg/mL Geometric Coefficient of Variation 34.2	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-21 Days of Pembrolizumab Cycle 8	1040 Day*μg/mL Geometric Coefficient of Variation 37.5	—	—	—	—	—	—	—	—	—	—	—	1040 Day*μg/mL Geometric Coefficient of Variation 37.5	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=435 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=204 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=40 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=41 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=20 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=38 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=20 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=57 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Cmax of Pembrolizumab Cycle 1	59.6 μg/mL Geometric Coefficient of Variation 29.6	58.5 μg/mL Geometric Coefficient of Variation 14.9	60.0 μg/mL Geometric Coefficient of Variation 22.1	52.8 μg/mL Geometric Coefficient of Variation 51.5	58.7 μg/mL Geometric Coefficient of Variation 32.3	74.2 μg/mL Geometric Coefficient of Variation 39.1	57.4 μg/mL Geometric Coefficient of Variation 32.8	63.9 μg/mL Geometric Coefficient of Variation 26.2	61.3 μg/mL Geometric Coefficient of Variation 19.2	55.5 μg/mL Geometric Coefficient of Variation 20.5	65.0 μg/mL Geometric Coefficient of Variation 34	59.6 μg/mL Geometric Coefficient of Variation 30.9	56.6 μg/mL Geometric Coefficient of Variation 25.6	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Pembrolizumab Cycle 2	67.5 μg/mL Geometric Coefficient of Variation 34.3	65.6 μg/mL Geometric Coefficient of Variation 21.2	78.7 μg/mL Geometric Coefficient of Variation 48.1	69.9 μg/mL Geometric Coefficient of Variation 37.1	66.7 μg/mL Geometric Coefficient of Variation 29.7	91.9 μg/mL Geometric Coefficient of Variation 14.1	67.6 μg/mL Geometric Coefficient of Variation 9.36	77.4 μg/mL Geometric Coefficient of Variation 33.7	67.0 μg/mL Geometric Coefficient of Variation 22.2	69.0 μg/mL Geometric Coefficient of Variation 22.6	—	69.9 μg/mL Geometric Coefficient of Variation 32.9	61.1 μg/mL Geometric Coefficient of Variation 55.1	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Pembrolizumab Cycle 3	36.4 μg/mL Geometric Coefficient of Variation 41.9	—	—	—	36.7 μg/mL Geometric Coefficient of Variation 44.2	—	—	35.1 μg/mL Geometric Coefficient of Variation 35.3	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Pembrolizumab Cycle 4	76.1 μg/mL Geometric Coefficient of Variation 30.2	79.6 μg/mL Geometric Coefficient of Variation 7.8	59.3 μg/mL Geometric Coefficient of Variation 50.1	83.7 μg/mL Geometric Coefficient of Variation 83	75.3 μg/mL Geometric Coefficient of Variation 26.6	61.2 μg/mL Geometric Coefficient of Variation NA NA= The Geometric Coefficient of Variation cannot be calculated for a single participant	56.9 μg/mL Geometric Coefficient of Variation 3.48	90.7 μg/mL Geometric Coefficient of Variation 34.5	75.1 μg/mL Geometric Coefficient of Variation 25.1	76.0 μg/mL Geometric Coefficient of Variation 28.7	—	73.4 μg/mL Geometric Coefficient of Variation 27.3	74.1 μg/mL Geometric Coefficient of Variation 37.4	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Pembrolizumab Cycle 8	93.8 μg/mL Geometric Coefficient of Variation 25.8	—	—	—	—	—	—	—	—	—	—	—	93.8 μg/mL Geometric Coefficient of Variation 25.8	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.

Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=3 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=6 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 Participants Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=195 Participants Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=3 Participants Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=39 Participants Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=18 Participants Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=36 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) n=20 Participants Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=57 Participants Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Predose Serum Concentration of Favezelimab Cycle 3	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.25	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 2.06	1.95 μg/mL Interval 0.0 to 29.9	0.225 μg/mL Interval 0.0 to 0.45	4.48 μg/mL Interval 4.48 to 4.48	28.2 μg/mL Interval 28.2 to 28.2	34.7 μg/mL Interval 32.3 to 36.8	23.7 μg/mL Interval 2.07 to 68.5	37.1 μg/mL Interval 3.31 to 389.0	14.8 μg/mL Interval 0.0 to 46.3	39.5 μg/mL Interval 3.81 to 81.3	35.8 μg/mL Interval 0.402 to 99.3	43.3 μg/mL Interval 6.34 to 119.0	19.1 μg/mL Interval 2.1 to 67.6	—	—	—	—	—	—	—
Predose Serum Concentration of Favezelimab Cycle 1	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	—	—	—	—	—	—	—
Predose Serum Concentration of Favezelimab Cycle 2	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	0.0361 μg/mL Interval 0.0 to 0.25	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.458	0.00 μg/mL Interval 0.0 to 1.87	1.52 μg/mL Interval 0.0 to 16.0	1.26 μg/mL Interval 0.361 to 2.24	3.28 μg/mL Interval 0.577 to 3.69	12.9 μg/mL Interval 11.7 to 20.7	23.6 μg/mL Interval 20.0 to 27.1	15.0 μg/mL Interval 1.62 to 50.0	21.8 μg/mL Interval 0.0 to 53.5	13.3 μg/mL Interval 0.0 to 45.1	25.2 μg/mL Interval 0.685 to 59.1	20.1 μg/mL Interval 0.0 to 62.7	27.0 μg/mL Interval 3.47 to 149.0	12.4 μg/mL Interval 0.0 to 58.1	—	—	—	—	—	—	—
Predose Serum Concentration of Favezelimab Cycle 4	—	0.00 μg/mL Interval 0.0 to 0.0	—	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 0.0	1.09 μg/mL Interval 0.0559 to 2.12	2.26 μg/mL Interval 0.0 to 19.3	0.429 μg/mL Interval 0.0 to 0.858	4.54 μg/mL Interval 4.54 to 4.54	—	31.0 μg/mL Interval 27.4 to 34.5	25.0 μg/mL Interval 2.51 to 76.1	42.0 μg/mL Interval 4.43 to 78.4	20.5 μg/mL Interval 0.0659 to 60.9	45.6 μg/mL Interval 6.2 to 85.1	38.4 μg/mL Interval 0.0 to 164.0	51.2 μg/mL Interval 7.08 to 128.0	16.8 μg/mL Interval 1.06 to 68.5	—	—	—	—	—	—	—
Predose Serum Concentration of Favezelimab Cycle 6	—	—	—	0.00 μg/mL Interval 0.0 to 0.0	15.1 μg/mL Interval 15.1 to 15.1	1.58 μg/mL Interval 0.0561 to 3.1	3.63 μg/mL Interval 0.0 to 19.2	50.6 μg/mL Interval 43.8 to 57.4	—	—	—	26.9 μg/mL Interval 6.53 to 113.0	35.1 μg/mL Interval 29.6 to 42.2	18.6 μg/mL Interval 0.729 to 68.4	40.3 μg/mL Interval 9.21 to 119.0	38.1 μg/mL Interval 1.14 to 119.0	59.6 μg/mL Interval 8.96 to 162.0	27.3 μg/mL Interval 0.464 to 246.0	—	—	—	—	—	—	—
Predose Serum Concentration of Favezelimab Cycle 8	—	0.00 μg/mL Interval 0.0 to 0.0	—	0.00 μg/mL Interval 0.0 to 0.0	—	1.09 μg/mL Interval 0.122 to 2.05	4.18 μg/mL Interval 0.0 to 13.7	0.00 μg/mL Interval 0.0 to 0.0	—	—	—	18.4 μg/mL Interval 9.48 to 113.0	30.8 μg/mL Interval 19.1 to 42.4	20.7 μg/mL Interval 5.62 to 35.9	51.1 μg/mL Interval 11.2 to 109.0	49.2 μg/mL Interval 1.48 to 161.0	64.3 μg/mL Interval 18.7 to 203.0	23.9 μg/mL Interval 0.289 to 84.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1

Population: All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=35 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
AUC0-inf of Lenvatinib Cycle 1	NA Day*ng/mL Geometric Coefficient of Variation NA NA= AUC0-inf could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-inf of Lenvatinib Cycle 2	NA Day*ng/mL Geometric Coefficient of Variation NA NA= AUC0-inf could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1

Population: All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=35 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
AUC0-21 Days of Lenvatinib Cycle 1	NA Day*ng/mL Geometric Coefficient of Variation NA NA= AUC0-21 Days could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
AUC0-21 Days of Lenvatinib Cycle 2	NA Day*ng/mL Geometric Coefficient of Variation NA NA= AUC0-21 Days could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1

Population: All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model

Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.

Outcome measures

Measure	Part A: Favezelimab 7 mg Monotherapy n=35 Participants Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: MK-4280A (Arm 5) Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Cmax of Lenvatinib Cycle 1	NA ng/mL Geometric Coefficient of Variation NA NA= Cmax Days could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Lenvatinib Cycle 2	NA ng/mL Geometric Coefficient of Variation NA NA= Cmax Days could not be calculated due to sparse data collection across participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Part A: Favezelimab 7 mg Monotherapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A: Favezelimab 21 mg Monotherapy

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Part A: Favezelimab 70 mg Monotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A: Favezelimab 210 mg Monotherapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A: Favezelimab 700 mg Monotherapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: Favezelimab 7 mg + Pembrolizumab 200 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A: Favezelimab 21 mg + Pembrolizumab 200 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: Favezelimab 70 mg + Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: Favezelimab 210 mg + Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A: Favezelimab 700 mg + Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part B: Favezelimab 800 mg Monotherapy (Arm 1)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 11 deaths

Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)

Serious events: 69 serious events

Other events: 185 other events

Deaths: 172 deaths

Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)

Serious events: 17 serious events

Other events: 39 other events

Deaths: 35 deaths

Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)

Serious events: 12 serious events

Other events: 40 other events

Deaths: 36 deaths

Part B: MK-4280A (Arm 5)

Serious events: 20 serious events

Other events: 54 other events

Deaths: 50 deaths

Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)

Serious events: 9 serious events

Other events: 20 other events

Deaths: 16 deaths

Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)

Serious events: 6 serious events

Other events: 20 other events

Deaths: 20 deaths

Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)

Serious events: 23 serious events

Other events: 40 other events

Deaths: 28 deaths

Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 9 deaths

Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 participants at risk Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 participants at risk Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 participants at risk Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 participants at risk Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 participants at risk Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=20 participants at risk Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=205 participants at risk Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=40 participants at risk Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: MK-4280A (Arm 5) n=58 participants at risk Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=40 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=9 participants at risk Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=1 participants at risk One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Angina pectoris	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Atrioventricular block complete	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Cardiac arrest	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Cardiac failure	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Myocardial infarction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Tachycardia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Hypophysitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Colitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Diverticular perforation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastric stenosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Ileus	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Inguinal hernia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Oesophageal perforation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Subileus	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Asthenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Chest pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Death	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders General physical health deterioration	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Pyrexia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Cholestasis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Anal abscess	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Bacteraemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Biliary tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Bronchitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations COVID-19	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations COVID-19 pneumonia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Febrile infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Hepatic infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Herpes zoster	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Liver abscess	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Meningitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Muscle abscess	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Neutropenic sepsis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Oesophageal candidiasis	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pelvic abscess	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Perirectal abscess	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 5/205 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pneumonia aspiration	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pseudomonas bronchitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pyelonephritis acute	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Respiratory tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Sepsis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Septic shock	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Skin infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Urosepsis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Stoma prolapse	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Amylase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood bilirubin increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Hepatic enzyme increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Platelet count decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Fulminant type 1 diabetes mellitus	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Aphasia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Cerebral artery embolism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Encephalopathy	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Hemiparesis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Neuralgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Seizure	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Spinal cord compression	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Syncope	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Product Issues Device dislocation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Completed suicide	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Confusional state	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Renal failure	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Ureteric stenosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Laryngeal granuloma	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Vascular disorders Lymphoedema	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event

Other adverse events

Measure	Part A: Favezelimab 7 mg Monotherapy n=3 participants at risk Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg Monotherapy n=6 participants at risk Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg Monotherapy n=3 participants at risk Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg Monotherapy n=3 participants at risk Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg Monotherapy n=3 participants at risk Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.	Part A: Favezelimab 7 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 21 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 70 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 210 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part A: Favezelimab 700 mg + Pembrolizumab 200 mg n=3 participants at risk Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg Monotherapy (Arm 1) n=20 participants at risk Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.	Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) n=205 participants at risk Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) n=40 participants at risk Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) n=41 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.	Part B: MK-4280A (Arm 5) n=58 participants at risk Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) n=20 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) n=20 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).	Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) n=40 participants at risk Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.	Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C) n=9 participants at risk Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.	Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A) n=1 participants at risk One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.5% 42/205 • Number of events 49 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 8/40 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	9.8% 4/41 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.5% 9/58 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.4% 11/205 • Number of events 18 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	40.0% 8/20 • Number of events 36 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Angina pectoris	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Cushingoid	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 15/205 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.2% 2/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	23.4% 48/205 • Number of events 50 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.0% 9/41 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.8% 8/58 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	40.0% 16/40 • Number of events 17 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.2% 2/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Eye disorders Vision blurred	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.4% 11/205 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.7% 26/205 • Number of events 26 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.3% 6/58 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	6.8% 14/205 • Number of events 14 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.7% 24/205 • Number of events 25 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 10/40 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.1% 7/41 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.1% 7/58 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	40.0% 8/20 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 8/40 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	18.5% 38/205 • Number of events 50 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 8/40 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.5% 9/58 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 14 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	55.0% 11/20 • Number of events 23 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	60.0% 24/40 • Number of events 45 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.4% 11/205 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Flatulence	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.0% 45/205 • Number of events 51 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	37.5% 15/40 • Number of events 18 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	19.5% 8/41 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.8% 8/58 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	55.0% 11/20 • Number of events 29 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	60.0% 12/20 • Number of events 16 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 12/40 • Number of events 19 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.2% 2/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Toothache	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 3/3 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 3/3 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.7% 28/205 • Number of events 32 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	9.8% 4/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	50.0% 10/20 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	55.0% 11/20 • Number of events 16 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	27.5% 11/40 • Number of events 19 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Asthenia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.7% 26/205 • Number of events 31 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.5% 9/40 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	14.6% 6/41 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.5% 9/40 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Chest pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Chills	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Face oedema	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Fatigue	100.0% 3/3 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 2/6 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 3/3 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	28.8% 59/205 • Number of events 63 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	37.5% 15/40 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	26.8% 11/41 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.7% 12/58 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	55.0% 11/20 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	40.0% 8/20 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	27.5% 11/40 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.2% 2/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Influenza like illness	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Mucosal inflammation	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.9% 12/205 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	6.9% 4/58 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Pyrexia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	18.5% 38/205 • Number of events 48 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.5% 9/40 • Number of events 17 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.1% 7/41 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
General disorders Temperature intolerance	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Immune system disorders Seasonal allergy	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Candida infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Cellulitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Cystitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Ear infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Herpes zoster	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Influenza	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Mastitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Nasopharyngitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Respiratory tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Skin infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.9% 6/205 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 10/205 • Number of events 20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Injury, poisoning and procedural complications Thermal burn	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.8% 16/205 • Number of events 18 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.0% 9/41 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 8/40 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Amylase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.2% 23/205 • Number of events 26 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.0% 9/41 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.3% 6/58 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	40.0% 8/20 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.5% 9/40 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.2% 21/205 • Number of events 23 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	14.6% 6/41 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.3% 6/58 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood bilirubin increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood creatinine increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.9% 12/205 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood lactate dehydrogenase increased	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Blood sodium decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Carcinoembryonic antigen increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Electrocardiogram T wave inversion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Gamma-glutamyltransferase increased	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.8% 18/205 • Number of events 20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	14.6% 6/41 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.3% 6/58 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Haemoglobin decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Lipase increased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 2/6 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Neutrophil count decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 14 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Platelet count decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 39 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations Weight decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Investigations White blood cell count decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 33 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.5% 42/205 • Number of events 45 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	32.5% 13/40 • Number of events 19 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.1% 7/41 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.7% 12/58 • Number of events 12 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	27.5% 11/40 • Number of events 14 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.1% 7/58 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.9% 12/205 • Number of events 17 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.8% 8/58 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	6.9% 4/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	9.8% 20/205 • Number of events 26 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.5% 9/58 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.3% 17/205 • Number of events 18 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 5/205 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	9.8% 4/41 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.3% 6/58 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 5/205 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Dizziness	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.4% 11/205 • Number of events 11 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Headache	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.8% 16/205 • Number of events 17 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Memory impairment	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	35.0% 7/20 • Number of events 15 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Ophthalmic migraine	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Paraesthesia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	30.0% 6/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Syncope	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Taste disorder	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Nervous system disorders Tremor	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Anxiety	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.9% 6/205 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.9% 12/205 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 4/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Psychiatric disorders Libido decreased	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Proteinuria	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	37.5% 15/40 • Number of events 22 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Reproductive system and breast disorders Breast pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Reproductive system and breast disorders Oedema genital	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 2/6 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.2% 27/205 • Number of events 28 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	24.4% 10/41 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.8% 8/58 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	20.0% 4/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 6/40 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Diaphragmalgia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.8% 16/205 • Number of events 16 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	19.5% 8/41 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.6% 5/58 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 5/205 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.98% 2/205 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	6.9% 4/58 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.0% 4/205 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.7% 1/58 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.4% 1/41 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 2/40 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 8 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Milia	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	1.5% 3/205 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 2/58 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.2% 21/205 • Number of events 21 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.2% 5/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.5% 9/58 • Number of events 13 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	22.2% 2/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	8.3% 17/205 • Number of events 19 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	12.5% 5/40 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	9.8% 4/41 • Number of events 5 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	13.8% 8/58 • Number of events 9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	15.0% 3/20 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	25.0% 5/20 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	17.5% 7/40 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	66.7% 2/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.4% 7/205 • Number of events 7 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.3% 3/41 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.2% 3/58 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	10.0% 2/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	11.1% 1/9 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Sensitive skin	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	7.5% 3/40 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Vascular disorders Diastolic hypertension	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/205 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	100.0% 1/1 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	16.7% 1/6 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.49% 1/205 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/40 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	4.9% 2/41 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	6.9% 4/58 • Number of events 4 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	67.5% 27/40 • Number of events 34 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
Vascular disorders Hypotension	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/6 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	33.3% 1/3 • Number of events 2 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	3.9% 8/205 • Number of events 10 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/41 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/58 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/20 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	5.0% 1/20 • Number of events 3 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	2.5% 1/40 • Number of events 1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/9 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event	0.00% 0/1 • Up to approximately 92 months AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" without hospitalization/death are excluded. Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER