Trial Outcomes & Findings for Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib (NCT NCT03778229)

Last Updated: 2026-04-23

Results Overview

Percentage of subjects with a confirmed Objective Response (OR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). OR includes Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in target lesion diameters). OR must be recorded at one visit and confirmed by repeat imaging at least 4 weeks later, with no disease progression between initial and confirmation visits.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

367 participants

Primary outcome timeframe

Time from randomization/first dose of study treatment to progression or last evaluable assessment in the absence of progressionuntil the end of the study, or an approximate maximum of 5.6 years.

Results posted on

2026-04-23

Participant Flow

Recruitment for the study involved prescreening with central FISH/IHC for MET amplification/overexpression. Eligible participants (FISH5+/IHC50+ for CSP v1.0-v6.0; FISH10+/IHC90+ for CSP v7.0) proceeded to screening for full eligibility. After screening, assignment or randomization to a treatment cohort depended on the applicable CSP version.

One site inadvertently processed a dosing transaction in IxRS causing the PRF enrollment number (367) to be higher than the enrollment number in the PRF (366).

Participant milestones

Participant milestones
Measure	Savo 300mg QD + Osi All patients assigned to savolitinib 300 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID + Osi All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 600mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID Monotherapy All patients assigned to savolitinib 300 mg bid + placebo and who received \>=1 dose of either study treatment.
Overall Study STARTED	196	101	44	25
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	196	101	44	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Savo 300mg QD + Osi All patients assigned to savolitinib 300 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID + Osi All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 600mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID Monotherapy All patients assigned to savolitinib 300 mg bid + placebo and who received \>=1 dose of either study treatment.
Overall Study Death	163	68	36	9
Overall Study Withdrawal by Subject	19	1	5	2
Overall Study Ongoing on-study	14	32	3	13
Overall Study Incorrectly Randomized	0	0	0	1

Baseline Characteristics

Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 mg QD + Osi n=196 Participants All patients assigned to savolitinib 300 mg qd + osimertinib and who have received \>=1 dose of either study drug.	Savo 300 mg BID + Osi n=101 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	600 mg QD + Osi n=44 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID Monotherapy n=24 Participants All patients assigned to savolitinib 300 mg bid + placebo and who received \>=1 dose of either study treatment.	Total n=365 Participants Total of all reporting groups
Age, Continuous	61.5 Years STANDARD_DEVIATION 11.27 • n=60 Participants	63.4 Years STANDARD_DEVIATION 10.89 • n=56 Participants	62.0 Years STANDARD_DEVIATION 12.14 • n=116 Participants	65.0 Years STANDARD_DEVIATION 10.64 • n=7 Participants	62.3 Years STANDARD_DEVIATION 11.24 • n=3 Participants
Sex: Female, Male Female	74 Participants n=60 Participants	29 Participants n=56 Participants	23 Participants n=116 Participants	9 Participants n=7 Participants	135 Participants n=3 Participants
Sex: Female, Male Male	122 Participants n=60 Participants	72 Participants n=56 Participants	21 Participants n=116 Participants	15 Participants n=7 Participants	230 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Asian	105 Participants n=60 Participants	31 Participants n=56 Participants	22 Participants n=116 Participants	12 Participants n=7 Participants	170 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=60 Participants	1 Participants n=56 Participants	3 Participants n=116 Participants	0 Participants n=7 Participants	4 Participants n=3 Participants
Race (NIH/OMB) White	77 Participants n=60 Participants	66 Participants n=56 Participants	18 Participants n=116 Participants	12 Participants n=7 Participants	173 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=60 Participants	3 Participants n=56 Participants	1 Participants n=116 Participants	0 Participants n=7 Participants	17 Participants n=3 Participants
Region of Enrollment Brazil	13 Participants n=60 Participants	2 Participants n=56 Participants	1 Participants n=116 Participants	0 Participants n=7 Participants	16 Participants n=3 Participants
Region of Enrollment CAN	13 Participants n=60 Participants	16 Participants n=56 Participants	6 Participants n=116 Participants	7 Participants n=7 Participants	42 Participants n=3 Participants
Region of Enrollment Chile	6 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	6 Participants n=3 Participants
Region of Enrollment Denmark	6 Participants n=60 Participants	2 Participants n=56 Participants	0 Participants n=116 Participants	1 Participants n=7 Participants	9 Participants n=3 Participants
Region of Enrollment Spain	3 Participants n=60 Participants	3 Participants n=56 Participants	3 Participants n=116 Participants	1 Participants n=7 Participants	10 Participants n=3 Participants
Region of Enrollment France	10 Participants n=60 Participants	2 Participants n=56 Participants	1 Participants n=116 Participants	0 Participants n=7 Participants	13 Participants n=3 Participants
Region of Enrollment India	6 Participants n=60 Participants	1 Participants n=56 Participants	1 Participants n=116 Participants	1 Participants n=7 Participants	9 Participants n=3 Participants
Region of Enrollment Italy	39 Participants n=60 Participants	47 Participants n=56 Participants	14 Participants n=116 Participants	5 Participants n=7 Participants	105 Participants n=3 Participants
Region of Enrollment Japan	18 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	18 Participants n=3 Participants
Region of Enrollment Korea, Republic Of	47 Participants n=60 Participants	7 Participants n=56 Participants	16 Participants n=116 Participants	4 Participants n=7 Participants	74 Participants n=3 Participants
Region of Enrollment Taiwan, China	7 Participants n=60 Participants	12 Participants n=56 Participants	2 Participants n=116 Participants	3 Participants n=7 Participants	24 Participants n=3 Participants
Region of Enrollment USA	21 Participants n=60 Participants	9 Participants n=56 Participants	0 Participants n=116 Participants	2 Participants n=7 Participants	32 Participants n=3 Participants
Region of Enrollment Viet Nam	7 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants	0 Participants n=7 Participants	7 Participants n=3 Participants

PRIMARY outcome

Timeframe: Time from randomization/first dose of study treatment to progression or last evaluable assessment in the absence of progressionuntil the end of the study, or an approximate maximum of 5.6 years.

Population: All patients assigned to savolitinib 300 mg bid + osimertinib with EGFRm+ and MET amplified/overexpressed (FISH10+ and/or IHC90+), locally advanced or metastatic NSCLC who have progressed following treatment with 1L osimertinib, and have taken \>=1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=80 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by Investigator Assessment; Target Population Analysis Set	56.3 Percent of subjects Interval 44.7 to 67.32	—	—

PRIMARY outcome

Timeframe: Time from randomization/first dose of study treatment to progression or last evaluable assessment in the absence of progression until the end of the study, or an approximate maximum of 5.6 years.

Population: All enrolled patients who received ≥1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=196 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by Investigator Assessment; 300 mg QD Safety Analysis Set	31.6 Percent of subjects Interval 25.19 to 38.64	—	—

SECONDARY outcome

Timeframe: Time from randomization/first dose of study treatment to progression or last evaluable assessment in the absence of progression until the end of the study, or an approximate maximum of 5.6 years.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=80 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by BICR Assessment; Target Population Analysis Set	55.0 Percent of subjects Interval 43.5 to 66.2	—	—

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Population: All patients with an objective response and assigned to savolitinib 300 mg bid + osimertinib who have FISH10+ and/or IHC90+ status, have progressed following 1L osimertinib, and have taken \>=1 dose of either study drug.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=45 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by Investigator Assessment; Target Population Analysis Set	7.13 Months Interval 5.55 to 9.63	—	—

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=44 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by BICR Assessment; Target Population Analysis Set	9.92 Months Interval 6.01 to 13.73	—	—

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to investigator assess progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Population: All patients assigned to savolitinib 300 mg bid + osimertinib who have FISH10+ and/or IHC90+ status, have progressed following 1L osimertinib, and have taken \>=1 dose of either study drug.

Median progression-free survival (PFS) was measured by investigator assessment using RECIST 1.1 and the Kaplan-Meier method. Progressive disease (PD) per RECIST 1.1 is defined as at least a 20% increase in the sum of target lesion diameters (with an absolute increase of ≥5 mm); unequivocal progression of non-target lesions, which may result from marked progression in a single lesion or multiple lesions; or the appearance of one or more unequivocal new lesions.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=80 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by Investigator Assessment; Target Population Analysis Set	7.39 Months Interval 5.49 to 7.62	—	—

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to BICR assessed progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Median progression-free survival (PFS) was measured by BICR assessment using RECIST 1.1 and the Kaplan-Meier method. Progressive disease (PD) per RECIST 1.1 is defined as at least a 20% increase in the sum of target lesion diameters (with an absolute increase of ≥5 mm); unequivocal progression of non-target lesions, which may result from marked progression in a single lesion or multiple lesions; or the appearance of one or more unequivocal new lesions.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=80 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by BICR Assessment; Target Population Analysis Set	7.52 Months Interval 6.37 to 11.33	—	—

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to all-cause death, assessed for up to 5.6 years.

Overall Survival (OS) from all-cause mortality

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=80 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Overall Survival (OS); Target Population Analysis Set	14.42 Months Interval 11.89 to 17.87	—	—

SECONDARY outcome

Population: All patients randomized under CSP version 7.0 with treatment groups assigned in accordance with the randomization, regardless of the treatment actually received.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=48 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=25 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by Investigator Assessment; Contribution of Components Analysis Set	54.2 Percent of subjects Interval 39.2 to 68.6	24.0 Percent of subjects Interval 9.4 to 45.1	—

SECONDARY outcome

Population: All patients randomized under CSP version 7.0 with treatment groups assigned in accordance with the randomization, regardless of the treatment actually received.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=48 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=25 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by BICR Assessment; Contribution of Components Analysis Set	58.3 Percent of subjects Interval 43.2 to 72.4	16.0 Percent of subjects Interval 4.5 to 36.1	—

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Population: All patients with an objective response and randomized under CSP version 7.0 with treatment groups assigned in accordance with the randomization, regardless of the treatment actually received.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=26 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=6 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by Investigator Assessment; Contribution of Components Analysis Set	7.95 Months Interval 4.9 to 11.73	4.71 Months Interval 2.56 to The 95% CI upper limit of median PFS was not estimable at this analysis due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=28 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=4 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by BICR Assessment; Contribution of Components Analysis Set	11.76 Months Interval 6.01 to The 95% CI upper limit of median PFS was not estimable at this analysis due to insufficient number of participants with events.	4.53 Months Interval 2.56 to The 95% CI upper limit of median PFS was not estimable at this analysis due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to investigator assess progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Population: All patients randomized under CSP version 7.0 with treatment groups assigned in accordance with the randomization, regardless of the treatment actually received.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=48 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=25 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by Investigator Assessment; Contribution of Components Analysis Set	7.56 Months Interval 5.55 to 11.04	2.66 Months Interval 1.41 to 4.11	—

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to BICR assessed progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Population: All patients randomized under CSP version 7.0 with treatment groups assigned in accordance with the randomization, regardless of the treatment actually received.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=48 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=25 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by BICR Assessment; Contribution of Components Analysis Set	8.28 Months Interval 5.82 to 15.08	3.65 Months Interval 1.41 to 5.75	—

SECONDARY outcome

Population: All enrolled patients who take ≥1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=101 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=44 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by Investigator Assessment; Safety Analysis Set	51.5 Percent of subjects Interval 41.3 to 61.6	31.8 Percent of subjects Interval 18.6 to 47.6	—

SECONDARY outcome

Population: All enrolled patients who take ≥1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=196 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=101 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=44 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Objective Response Rate (ORR) by BICR Assessment; Safety Analysis Set	32.7 Percent of subjects Interval 26.1 to 39.7	49.5 Percent of subjects Interval 39.4 to 59.6	34.1 Percent of subjects Interval 20.5 to 49.9

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Population: All enrolled patients with an objective response and who take ≥1 dose of either study drug.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=62 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=52 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=14 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by Investigator Assessment; Safety Analysis Set	8.54 Months Interval 7.56 to 10.51	6.01 Months Interval 4.9 to 9.07	8.59 Months Interval 3.94 to 21.95

SECONDARY outcome

Timeframe: From date of first confirmed objective response to progressive disease in accordance with RECIST1.1 or death from any cause, whichever came first; assessed for up to 5.6 years.

Population: All enrolled patients who take ≥1 dose of either study drug and with an objective response.

Median time of response for patients with an investigator assessed confirmed objective response per RECIST1.1

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=64 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=50 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=15 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Duration of Response (DoR) by BICR Assessment; Safety Analysis Set	9.66 Months Interval 7.49 to 13.17	9.92 Months Interval 6.11 to 12.42	18.86 Months Interval 7.72 to 24.67

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to all-cause death, assessed for up to 5.6 years.

Population: All enrolled patients who take ≥1 dose of either study drug

Overall Survival (OS) from all-cause mortality

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=196 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=101 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=44 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Overall Survival (OS); Safety Analysis Set	14.75 Months Interval 12.88 to 17.02	13.90 Months Interval 11.76 to 15.87	15.08 Months Interval 9.17 to 18.6

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to investigator assess progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Population: All enrolled patients who take ≥1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=196 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=101 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=44 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by Investigator Assessment; Safety Analysis Set	5.29 Months Interval 4.17 to 5.78	5.68 Months Interval 4.27 to 7.39	4.40 Months Interval 2.56 to 7.43

SECONDARY outcome

Timeframe: Time from randomization/start of study treatment to BICR assessed progressive disease per RECIST1.1 or death, assessed for up to 5.6 years.

Population: All enrolled patients who take ≥1 dose of either study drug.

Outcome measures

Outcome measures
Measure	Savo 300 mg BID + Osi n=196 Participants All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 300 mg BID Monotherapy n=101 Participants All patients randomized to savolitinib 300 mg bid + placebo.	Savo 600 mg QD + Osi n=44 Participants All patients assigned to savolitinib 600 mg qd + osimertinib and who have received \>=1 dose of either study drug.
Progression-free Survival (PFS) by BICR Assessment; Safety Analysis Set	5.55 Months Interval 4.86 to 7.36	7.39 Months Interval 5.59 to 9.2	4.44 Months Interval 2.53 to 9.33

Adverse Events

Savo 300mg QD + Osi

Serious events: 62 serious events

Other events: 185 other events

Deaths: 164 deaths

Savo 300mg BID + Osi

Serious events: 31 serious events

Other events: 99 other events

Deaths: 68 deaths

Savo 600mg QD + Osi

Serious events: 20 serious events

Other events: 42 other events

Deaths: 37 deaths

Savo 300mg BID Monotherapy

Serious events: 8 serious events

Other events: 22 other events

Deaths: 9 deaths

Cross-over

Serious events: 1 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Savo 300mg QD + Osi n=196 participants at risk All patients assigned to savolitinib 300 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID + Osi n=101 participants at risk All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 600mg QD + Osi n=44 participants at risk All patients assigned to savolitinib 600 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID Monotherapy n=24 participants at risk All patients assigned to savolitinib 300 mg bid + placebo and who received \>=1 dose of either study treatment.	Cross-over n=14 participants at risk Includes all subjects randomized to Savolitinib 300 mg BID + placebo, who crossed over to Savolitinib 300 mg BID + Osimertinib 80 mg QD after disease progression.
Cardiac disorders Right ventricular failure	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Cerebrovascular accident	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Dizziness	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Epilepsy	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Haemorrhage intracranial	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Headache	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Hydrocephalus	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Petit mal epilepsy	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Transient ischaemic attack	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Psychiatric disorders Delirium	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Ventricular tachycardia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Psychiatric disorders Disorientation	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Psychiatric disorders Mental status changes	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Renal and urinary disorders Acute kidney injury	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Renal and urinary disorders Nephrolithiasis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Ear and labyrinth disorders Inner ear disorder	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 4/196 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 4/196 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.1% 8/196 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 3/196 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Surgical and medical procedures Transurethral bladder resection	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Vascular disorders Deep vein thrombosis	1.5% 3/196 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Colitis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Faecaloma	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Haematemesis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Haemorrhoids	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Nausea	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Oesophageal stenosis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Pancreatitis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Stomatitis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Vomiting	1.5% 3/196 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Asthenia	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Chest discomfort	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Death	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Fatigue	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders General physical health deterioration	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Hyperpyrexia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Non-cardiac chest pain	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Oedema	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Oedema peripheral	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Peripheral swelling	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Pyrexia	2.0% 4/196 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Immune system disorders Anaphylactic reaction	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Immune system disorders Anaphylactic shock	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Immune system disorders Hypersensitivity	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Appendicitis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Covid-19	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Cellulitis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Colonic abscess	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Atrial fibrillation	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Erysipelas	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Extradural abscess	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Large intestine infection	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Ophthalmic herpes zoster	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Pneumonia	3.1% 6/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.0% 4/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Pneumonia aspiration	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Rash pustular	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Sepsis	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Cardiac arrest	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Urinary tract infection	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Hand fracture	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Pelvic fracture	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Pneumonitis chemical	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Procedural pain	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Alanine aminotransferase increased	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Myocardial infarction	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Aspartate aminotransferase increased	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Hepatic enzyme increased	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Neutrophil count decreased	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Sars-cov-2 test positive	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Myocardial ischaemia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Back pain	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Bone pain	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Cardiac disorders Pericardial effusion	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Brain oedema	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Cerebral infarction	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Cerebral ischaemia	0.51% 1/196 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.

Other adverse events

Other adverse events
Measure	Savo 300mg QD + Osi n=196 participants at risk All patients assigned to savolitinib 300 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID + Osi n=101 participants at risk All patients assigned to savolitinib 300 mg bid + osimertinib and who received \>=1 dose of either study treatment.	Savo 600mg QD + Osi n=44 participants at risk All patients assigned to savolitinib 600 mg qd + osimertinib and who received \>=1 dose of either study treatment.	Savo 300mg BID Monotherapy n=24 participants at risk All patients assigned to savolitinib 300 mg bid + placebo and who received \>=1 dose of either study treatment.	Cross-over n=14 participants at risk Includes all subjects randomized to Savolitinib 300 mg BID + placebo, who crossed over to Savolitinib 300 mg BID + Osimertinib 80 mg QD after disease progression.
Nervous system disorders Dizziness	8.7% 17/196 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.9% 9/101 • Number of events 12 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.6% 6/44 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Headache	11.2% 22/196 • Number of events 31 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.9% 9/101 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Nervous system disorders Hypoaesthesia	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	3.0% 3/101 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Psychiatric disorders Insomnia	7.1% 14/196 • Number of events 14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.0% 5/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Renal and urinary disorders Dysuria	3.6% 7/196 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 26/196 • Number of events 29 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.9% 15/101 • Number of events 17 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.6% 6/44 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	16.7% 4/24 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.3% 30/196 • Number of events 33 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	18.8% 19/101 • Number of events 22 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	18.2% 8/44 • Number of events 12 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 4/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Productive cough	5.1% 10/196 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.6% 6/44 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.6% 7/196 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.9% 10/101 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Abdominal pain	5.1% 10/196 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.0% 5/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	12.5% 3/24 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Dermatitis acneiform	5.1% 10/196 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.0% 4/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Dry skin	6.1% 12/196 • Number of events 16 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.0% 4/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Pruritus	9.7% 19/196 • Number of events 22 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.9% 12/101 • Number of events 15 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.6% 6/44 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Rash	12.8% 25/196 • Number of events 27 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.9% 12/101 • Number of events 18 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	15.9% 7/44 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Vascular disorders Deep vein thrombosis	3.1% 6/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.9% 8/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	15.9% 7/44 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Vascular disorders Embolism	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.9% 7/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Vascular disorders Hypotension	3.6% 7/196 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.9% 7/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Abdominal pain upper	5.1% 10/196 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.9% 9/101 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Constipation	15.3% 30/196 • Number of events 34 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.9% 15/101 • Number of events 15 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	20.5% 9/44 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Diarrhoea	17.9% 35/196 • Number of events 56 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	32.7% 33/101 • Number of events 52 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	25.0% 11/44 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Blood and lymphatic system disorders Anaemia	9.2% 18/196 • Number of events 23 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.9% 8/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	20.5% 9/44 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.6% 5/196 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.0% 5/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Nausea	39.3% 77/196 • Number of events 91 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	44.6% 45/101 • Number of events 61 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	34.1% 15/44 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	20.8% 5/24 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Stomatitis	4.6% 9/196 • Number of events 17 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Gastrointestinal disorders Vomiting	19.4% 38/196 • Number of events 65 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	20.8% 21/101 • Number of events 37 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	27.3% 12/44 • Number of events 17 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	12.5% 3/24 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Asthenia	10.2% 20/196 • Number of events 21 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	18.8% 19/101 • Number of events 21 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.1% 4/44 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Blood and lymphatic system disorders Neutropenia	3.6% 7/196 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.9% 7/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.1% 4/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Chills	2.6% 5/196 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Fatigue	19.4% 38/196 • Number of events 42 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	16.8% 17/101 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	20.5% 9/44 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	16.7% 4/24 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Oedema peripheral	40.3% 79/196 • Number of events 108 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	58.4% 59/101 • Number of events 91 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	43.2% 19/44 • Number of events 28 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	41.7% 10/24 • Number of events 15 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	35.7% 5/14 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Blood and lymphatic system disorders Thrombocytopenia	2.0% 4/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.9% 9/101 • Number of events 9 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Pyrexia	12.8% 25/196 • Number of events 27 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	17.8% 18/101 • Number of events 24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	25.0% 11/44 • Number of events 12 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Covid-19	3.1% 6/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.9% 12/101 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Paronychia	18.9% 37/196 • Number of events 47 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.9% 14/101 • Number of events 17 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	15.9% 7/44 • Number of events 9 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Pneumonia	3.1% 6/196 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Upper respiratory tract infection	3.1% 6/196 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Urinary tract infection	4.1% 8/196 • Number of events 9 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.9% 12/101 • Number of events 14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.1% 4/44 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Alanine aminotransferase increased	6.6% 13/196 • Number of events 16 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.9% 10/101 • Number of events 12 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	15.9% 7/44 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Amylase increased	4.6% 9/196 • Number of events 9 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	10.9% 11/101 • Number of events 16 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Aspartate aminotransferase increased	7.1% 14/196 • Number of events 21 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	13.6% 6/44 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Blood alkaline phosphatase increased	3.6% 7/196 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.9% 7/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Blood creatinine increased	5.6% 11/196 • Number of events 15 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.1% 4/44 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Blood lactate dehydrogenase increased	1.0% 2/196 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	3.0% 3/101 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Neutrophil count decreased	6.1% 12/196 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	3.0% 3/101 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Platelet count decreased	3.6% 7/196 • Number of events 9 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.9% 6/101 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.1% 4/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations Weight decreased	3.6% 7/196 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.0% 4/101 • Number of events 4 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Investigations White blood cell count decreased	5.1% 10/196 • Number of events 14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.99% 1/101 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Decreased appetite	20.9% 41/196 • Number of events 44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	12.9% 13/101 • Number of events 14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	27.3% 12/44 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	12.5% 3/24 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hypoalbuminaemia	8.7% 17/196 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.9% 15/101 • Number of events 26 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.8% 3/44 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hypocalcaemia	8.2% 16/196 • Number of events 19 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	9.9% 10/101 • Number of events 11 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hypokalaemia	3.1% 6/196 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.9% 8/101 • Number of events 8 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hyponatraemia	4.1% 8/196 • Number of events 10 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 3 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Arthralgia	13.8% 27/196 • Number of events 30 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.9% 12/101 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Back pain	6.1% 12/196 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.9% 15/101 • Number of events 16 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	15.9% 7/44 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Muscle spasms	6.6% 13/196 • Number of events 13 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	6.9% 7/101 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.3% 1/44 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 17/196 • Number of events 20 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	5.0% 5/101 • Number of events 6 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.5% 2/44 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Neck pain	2.6% 5/196 • Number of events 5 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	2.0% 2/101 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	8.3% 2/24 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/14 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Musculoskeletal and connective tissue disorders Pain in extremity	8.7% 17/196 • Number of events 18 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	10.9% 11/101 • Number of events 15 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	11.4% 5/44 • Number of events 7 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	4.2% 1/24 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Psychiatric disorders Anxiety	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Endocrine disorders Cushingoid	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Infections and infestations Cystitis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Face oedema	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Generalised oedema	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	14.3% 2/14 • Number of events 2 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
General disorders Influenza like illness	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Eye disorders Lacrimation increased	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Renal and urinary disorders Pollakiuria	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/196 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/101 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/44 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	0.00% 0/24 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.	7.1% 1/14 • Number of events 1 • AEs with an onset date or worsening on or after the first dose and up to and including 35 days after the last dose of study treatment, or prior to the initiation of crossover treatment, or start of subsequent anti-cancer therapy. Cross-over period includes AEs with an onset or worsening on or after start of crossover therapy and up to 35 days following the last dose of crossover treatment or start of subsequent anti-cancer therapy. Followed for a maximum of 5.6 years.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place